New Rulebook for Prostate Cancer Trials:
What PCWG4 Means for You
Bottom Line Up Front (BLUF)
An international panel of more than 40 prostate cancer specialists has issued a landmark update — the Prostate Cancer Working Group 4 (PCWG4) report — that rewrites the standards used to design and conduct clinical trials for advanced prostate cancer. Published in February 2026 in the Journal of Clinical Oncology, PCWG4 replaces stigmatizing "castration" language with biology-based terminology, formally integrates the powerful PSMA-PET scan into trial rules, refines how progression is measured so patients are not pulled from beneficial treatments prematurely, and demands that patient quality-of-life be measured as rigorously as tumor shrinkage. For IPCSG members, these changes matter because they will directly shape which trials you can enter, how your disease state is described, and how quickly promising drugs reach approval.
A Word Before We Start: The Terminology Treadmill
Every few years, prostate cancer patients encounter a new set of terms on their pathology reports, in their oncologist's notes, and in the research articles they have worked hard to understand — and the old terms have quietly disappeared. Gleason scores gave way to Grade Groups. "Hormone-sensitive" became "castration-sensitive," then — with PCWG4 — something else entirely. CRPC, mCRPC, nmCRPC, HSPC, mHSPC, CSPC: the alphabet soup expands with each publication cycle. It is entirely reasonable to feel that the medical establishment is moving the goalposts, or worse, deliberately speaking over your head.
The frustration is legitimate. But there is a practical reason to push through it: the words on your chart control what options are available to you. Clinical trial eligibility criteria are written in this technical language. Insurance prior-authorization forms use it. When you or a family member call a trials hotline, the intake coordinator is matching your disease description against a checklist written in the current vocabulary. A patient who walks in still using 2016 PCWG3 terminology — "I have mCRPC" — may not realize that PCWG4 now subdivides that category in ways that open doors to trials he previously would not have qualified for, or that change how his imaging results are interpreted.
Consider the Gleason-to-Grade-Group transition as a cautionary example. The switch was well-intentioned: Gleason 6 cancers were being over-treated because patients — and some physicians — heard "6 out of 10" and assumed the disease was moderately aggressive, when in fact Gleason 6 is the lowest score a pathologist will assign. Grade Group 1 (the new equivalent) communicates the same biology more honestly. But the transition created years of confusion for men who had been told they were a "Gleason 7" and now found "Grade Group 3" on a new report from a different institution — same tumor, same prognosis, completely different-looking label. Without a guide, that discrepancy looks like deterioration.
The terminology in the PCWG4 report you are about to read is another such transition. The changes are driven by real science, not academic housekeeping — and we will explain that science in plain language section by section. But the broader point stands: keeping a personal medical vocabulary log is now a practical survival skill for the engaged prostate cancer patient. Note the date each term first appeared on your records, what it replaced, and what treatment decisions it was connected to. Your IPCSG support group, your oncology team, and resources like this newsletter exist precisely to help you maintain that log without having to wade through 17-page journal articles on your own.
The stakes extend well beyond the clinic. The same terminology gap that can exclude you from a clinical trial can also delay or deny insurance coverage for an approved therapy — because prior-authorization reviewers match chart language against coverage policy criteria word by word, not concept by concept. And for men who still carry life insurance or long-term care policies, or who are applying for new coverage, insurance underwriters use the exact words in your medical record to assign risk ratings — ratings that may not reflect current science if the underwriter's manual is running two terminology cycles behind the clinic. That dimension of the vocabulary problem is explored in the sidebar below.
With that context established, here is what PCWG4 actually says — and what it means for you.
Insurance decisions — both for treatment coverage and for underwriting of life, disability, and long-term care policies — are made by people working from documents: coverage policies, underwriting manuals, and prior-authorization criteria. Those documents are written in medical terminology. When the terminology in your chart does not match the terminology in those documents, coverage problems follow, regardless of whether the underlying clinical facts support coverage.
Prior Authorization: The Lu-177 PSMA Case Study
The sharpest current example involves lutetium-177 PSMA-617 (Pluvicto®), the radioligand therapy that targets prostate cancer cells expressing the PSMA protein. When the FDA first approved Pluvicto in March 2022, the label required that patients have already received both an androgen receptor pathway inhibitor (ARPI, such as enzalutamide or abiraterone) and taxane-based chemotherapy. Insurers wrote their coverage policies to mirror that label — and prior-authorization reviewers were trained to deny claims that did not document prior taxane use.
In March 2025, the FDA expanded the Pluvicto label. Based on the phase III PSMAfore trial published in The Lancet, men who are taxane-naive — meaning they have never received chemotherapy — may now receive Pluvicto after ARPI failure, without waiting for chemotherapy first. That is a significant expansion of eligible patients.
But coverage policies at individual insurers and Medicare Advantage plans do not update automatically when an FDA label changes. They are revised through internal review processes that can lag by months or longer. During that gap, a prior-authorization reviewer may deny a claim for a taxane-naive patient even though the drug is now FDA-approved for that indication — because the insurer's policy still reflects the 2022 label language. The solution is documentation: your oncologist's prior-authorization request must explicitly cite the current FDA label, the PSMAfore trial, and the patient's PCWG4-defined disease state (Metastatic APMR, post-ARPI, taxane-naive) to give the reviewer the vocabulary bridge they need to approve the claim.
NCCN Guidelines: The Middle Layer
Most major commercial insurers and Medicare use NCCN Guideline recommendations as a secondary benchmark for coverage decisions, particularly for treatments used off-label or in sequence orders not explicitly addressed by an FDA label. NCCN guidelines are updated more frequently than insurer policies but still lag primary literature — typically by one to two update cycles after a major trial publication. PCWG4 terminology will propagate into NCCN prostate cancer guidelines over the next one to two years. Until that happens, a prior-auth request citing PCWG4's APMR classification may not be recognized by a reviewer whose policy cross-references only NCCN language. Again, the bridge must be built explicitly in the documentation.
Life and Long-Term Care Insurance: The Underwriting Problem
Insurance underwriting — the process by which life, disability, and long-term care insurers assess risk and set premiums — relies on actuarial tables and medical underwriting manuals that are revised far less frequently than clinical guidelines. A man applying for a new life insurance policy today may find that the underwriter's manual still classifies "castration-resistant prostate cancer" as a single, uniformly high-risk category — making no distinction between nonmetastatic APMR with biochemical recurrence only (a condition compatible with many years of stable, well-managed life) and metastatic APMR with visceral involvement (a significantly more urgent situation).
In practice, this means a man with nonmetastatic APMR — PCWG4 language that did not exist in standard documentation before 2026 — applying for coverage may receive an automatic table rating or outright denial based on the blunt "CRPC" label that still appears in older sections of his medical record, even if his current disease burden is genuinely low. The PCWG4 distinction between nonmetastatic and metastatic APMR, and between APMR "specified by previous therapy" categories, provides documentation tools that, over time, will allow underwriters to make more granular risk assessments — but only after the underwriting manuals catch up.
For men who anticipate applying for life or long-term care coverage, the practical advice is to work with an insurance broker experienced in cancer history applications and to provide a physician's narrative letter that translates the chart terminology into plain language, specifies the current disease extent precisely, and distinguishes clearly between historical labels and current clinical status.
What You Can Do Right Now
- Ask your oncologist to include your PCWG4 disease classification (APMN, APMS, or APMR; metastatic or nonmetastatic; imaging modality used) in every clinical note and referral letter going forward.
- When submitting a prior-authorization request, verify that your oncologist's letter explicitly cites the current FDA label date and the relevant supporting trial — not just a drug name.
- If a prior authorization is denied, request the specific coverage policy language the reviewer applied, then compare it to the current FDA label and NCCN guideline. Terminology mismatches are among the most common and most correctable denial reasons.
- For life or long-term care insurance applications, request a physician's narrative letter that describes your current disease burden in clear, non-jargon terms alongside the technical classification — and that explicitly states what the older label in your record meant at the time it was applied.
- Keep your own terminology log: for each major label change in your medical record, note the date, the old term, the new term, and the clinical context. That log is your translation key when insurers, underwriters, or new providers read your history through outdated vocabulary.
The two diagrams divide the story cleanly. The classification flowchart answers "how do I know which box I'm in?" — tracing from treatment history at the top, through the three disease state labels in the middle, down to the three characterization factors that every state requires. The eligibility matrix then answers "so what?" — reading down each column shows a patient exactly what PSA threshold applies to them, what scans will be needed, how progression will be judged, and what category of trials is currently being designed for their disease state. Interactive version of diagrams
Background: Why Clinical Trial Rules Matter to Patients
When a new prostate cancer drug is tested in a clinical trial, researchers must answer consistent questions: Who qualifies to enroll? How is the disease classified at the start? How do we know the drug is working — or failing? When should a patient be taken off a trial? The answers to these questions are not left to individual investigators. Instead, the prostate cancer research community periodically convenes expert working groups to establish shared standards, so that data from trials conducted in Tokyo, Toronto, and San Diego can be meaningfully compared.
The Prostate Cancer Clinical Trials Working Group has issued guidance roughly every decade. PCWG2 appeared in 2008; PCWG3 followed in 2016. The new PCWG4 report reflects a decade of remarkable progress: multiple new drug approvals, the rise of PSMA-targeted imaging and therapy, and a growing recognition that the old vocabulary was misleading patients and their families. The effort involved more than 40 clinicians and scientists working in subcommittees from 2016 through 2025, with the formal paper accepted by JCO on January 7, 2026, and published February 26, 2026. It was simultaneously presented at the 2026 ASCO GU Symposium in San Francisco.
Change #1 — New Language, New Respect
The most visible change in PCWG4 is a deliberate shift away from the terms "castration-sensitive" and "castration-resistant" prostate cancer — shorthand that has appeared on pathology reports, consent forms, and insurance documents for years. Many patients and advocates have long objected to language that frames the disease around surgical or chemical castration and implies that the patient has "resisted" treatment — a word that can carry an unintended blame.
PCWG4 replaces the old terms with three categories based on Androgen Pathway Modulation (APM) — the technical term for hormonal therapies that reduce or block testosterone's effect on cancer cells.
| New PCWG4 Term | Abbreviation | What It Means in Plain Language | Old Term It Replaces |
|---|---|---|---|
| APM-Naïve | APMN | Never received hormonal therapy for prostate cancer | Hormone-sensitive (treatment-naïve) |
| APM-Sensitive | APMS | Has received hormonal therapy and is still responding to it | Castration-sensitive / hormone-sensitive |
| APM-Resistant | APMR | Cancer is growing despite hormonal therapy | Castration-resistant (CRPC) |
PCWG4 also replaces the term "disease state" with "treatment indication," a subtle but important shift: the focus is now on the specific unmet medical need — what the patient needs next — rather than a fixed category the patient is placed into.
In practical terms, a patient at UCSD Moores or any major cancer center may soon see "Metastatic APMR" on their chart rather than "mCRPC." The underlying biology is identical; the framing is more accurate and less stigmatizing.
Change #2 — PSMA-PET Moves from Experimental to Standard
PSMA-PET scans work by injecting a radioactive tracer that binds to a protein — prostate-specific membrane antigen — that is overexpressed on prostate cancer cells. The resulting scan reveals cancer deposits with far greater sensitivity than traditional CT scans or bone scans. Multiple agents are now FDA-approved for PSMA-PET imaging, including 68Ga-PSMA-11 (Locametz® and Illuccix®) and 18F-DCFPyL (Pylarify®). A fourth agent, Gozellix®, received FDA approval in March 2025.
PCWG3, written in 2016, could not incorporate PSMA-PET because it was still in development. PCWG4 formally designates PSMA-PET as noninvestigational for staging and for demonstrating disease distribution in patients with recurrent cancer. However, PCWG4 is honest about what remains unknown: PSMA-PET is still investigational for measuring treatment response and disease progression, because the field has not yet validated reliable standards for what constitutes a meaningful change on the scan.
If you are considering enrolling in a clinical trial, expect that many trials will now require a PSMA-PET scan at the outset — ideally alongside (not instead of) a CT scan with IV contrast and a bone scan. Trials may classify your disease based exclusively on PSMA-PET findings, on conventional imaging, or both, but whichever approach is used must be specified upfront and recorded consistently.
Ask your oncologist: "Is PSMA-PET available and covered for me at this stage, and does the trial I'm considering require one?"
Change #3 — Defining Progression More Carefully
One of the most consequential PCWG4 changes involves how trial investigators decide that a patient's disease is "progressing" and that the therapy is no longer working. This matters enormously: call progression too early, and you pull a patient from a drug that might still be helping. Call it too late, and a patient languishes on an ineffective therapy while their cancer accelerates.
Bone Scan: The "2+2" Rule Gets a Safety Override
The previous PCWG3 rules required that at least two new bone lesions appear on the first post-treatment scan, then be confirmed by at least two more new lesions on a follow-up scan several weeks later — the so-called "2+2" rule. This confirmatory requirement was designed to avoid false alarms from scan artifacts or inflammation (a phenomenon called "flare"). PCWG4 retains this conservative rule for patients with modest progression (five or fewer new lesions). However, it adds an important safety valve: if a restaging bone scan shows six or more new lesions, the confirmatory scan is no longer required. Waiting weeks for confirmation when cancer is spreading rapidly is potentially harmful, and PCWG4 closes that gap.
PSMA-PET Progression: New Lesions Only, Not SUV Changes
PCWG4 takes a clear position on PSMA-PET-based progression: it must be defined by the appearance of new lesions, not by changes in the radiotracer uptake value (called SUV) of existing lesions. This distinction matters because SUV measurements vary depending on the scanner, the tracer used, and how long after injection the images are taken. Using SUV thresholds as a progression trigger would lead to inconsistent calls across different hospitals and countries.
For PSMA-PET-defined progression in bone and lymph nodes, the same two-plus-two logic applies for five or fewer new lesions, with six or more requiring no confirmation. For new lesions in the liver and other non-pulmonary organs, even a single new PSMA-avid lesion is enough to call progression — reflecting the serious clinical significance of visceral spread.
PCWG4 also wisely cautions that PSMA expression on cancer cells can be temporarily suppressed by some hormone therapies early in treatment, which can make scans misleading. For this reason, any PSMA-PET performed within the first eight weeks of a new therapy is excluded from progression analysis.
PSA Alone Can No Longer Pull You Off a Trial
PSA (Prostate-Specific Antigen) has been used as a surrogate marker of prostate cancer activity for decades. But multiple large trials — including PREVAIL with enzalutamide and ARCHES with enzalutamide — have documented that patients receiving next-generation hormone therapies sometimes show measurable tumor shrinkage on imaging even as their PSA continues to rise, at least temporarily. The reverse is also true: PSA can appear stable while the cancer silently spreads to new sites visible only on imaging.
PCWG4 responds to this disconnect by redefining PSA progression as informational, not automatically actionable. A PSA rise must be confirmed by a second rising measurement taken at least 21 days later, and must show a minimum absolute increase of 0.2 ng/mL to filter out measurement noise. Even confirmed PSA progression alone is not sufficient justification to change therapy in a trial setting — the patient's overall clinical picture must be weighed.
— Armstrong et al., JCO, February 2026
Change #4 — "No Longer Clinically Benefiting" Replaces Rigid Stop Rules
Historically, many clinical trials used rigid, protocol-mandated stop points: once a patient's imaging showed defined progression, the trial drug was discontinued regardless of how the patient felt. PCWG4 formalizes an alternative concept that PCWG3 had introduced: No Longer Clinically Benefiting (NLCB).
A patient is "no longer clinically benefiting" only when they experience clear disease-related deterioration — meaningful pain progression, cancer-related weight loss, or functional decline — that cannot be addressed by targeting a single progressive lesion with local treatment such as radiation. Critically, the NLCB threshold is attributed to disease, not to treatment side effects.
This matters practically: under NLCB rules, a patient who shows two new bone lesions on imaging but feels well and is functioning normally may continue on the trial drug — especially if the rest of the disease appears controlled. The trial still records the imaging-based progression date for statistical purposes, but the patient is not automatically removed from therapy. This aligns more closely with real-world oncology practice, where experienced oncologists routinely continue effective therapies past imaging-defined thresholds.
Change #5 — Biomarkers Beyond PSA
PCWG4 elevates two emerging blood tests to near-term priority status as candidate biomarkers for measuring treatment response:
Circulating Tumor Cells (CTCs)
Prostate cancer cells occasionally shed into the bloodstream. The FDA has cleared an assay for counting these circulating tumor cells (CTCs) in a 7.5 mL blood sample. Studies published through 2025 have shown that patients who achieve zero detectable CTCs after treatment (designated "CTC0") have meaningfully better survival than those who do not. PCWG4 identifies CTC0 as one of four blood-based response biomarkers likely to move toward formal qualification — though it cautions that CTCs have not yet been validated as regulatory surrogates for overall survival in all disease settings or with all drug classes.
Circulating Tumor DNA (ctDNA)
When cancer cells die, they release fragments of their DNA into the bloodstream. Laboratory tests can detect and measure this ctDNA, providing a "liquid biopsy" snapshot of the tumor's genetic activity without a needle in the back. A 2026 meta-analysis published in Frontiers in Immunology examined 24 studies involving more than 5,200 patients with castration-resistant prostate cancer and confirmed that high baseline ctDNA levels consistently predict worse overall survival. A 2025 study published in The Oncologist showed that ctDNA can track disease progression more granularly than conventional imaging by reflecting different metastatic patterns.
PCWG4 recommends collecting ctDNA samples at baseline and at regular intervals during trials — roughly every eight to twelve weeks — and formally recording both the presence or absence of ctDNA and its tumor fraction. These data will build the validation evidence needed for eventual regulatory use.
If you are enrolled in a clinical trial, you may be asked to provide regular blood samples beyond routine labs. These "liquid biopsy" collections — for CTC counts or ctDNA analysis — are minimally invasive (a standard blood draw) and represent some of the most scientifically important data the trial will generate. Participating fully is worth it.
Change #6 — Your Quality of Life Is Now a Required Measurement
Previous working groups recommended collecting patient-reported outcomes (PROs) in trials but left much of the methodology to individual investigators. PCWG4 is more prescriptive: it requires that quality-of-life assessments using validated instruments be built into trial protocols from the design stage, with appropriate statistical methodology specified in advance.
The domains PCWG4 highlights as most important for prostate cancer trials include:
- Pain intensity and interference (using the Brief Pain Inventory)
- Physical functioning (using PROMIS Physical Function scales)
- Disease-specific quality of life (using FACT-P or EPIC instruments)
- Fatigue, urinary symptoms, sexual function, and hormonal symptoms where relevant
- Patient-reported adverse events (using the NCI PRO-CTCAE tool)
PCWG4 recommends that investigators present the probability of achieving a "minimal clinically important difference" — the threshold at which patients actually feel a change — not just report average scores. It also advocates for time-to-event analyses of quality-of-life deterioration, so that trials can show how long patients maintained good function, not just whether they eventually declined.
Change #7 — Broader Eligibility and Equity Requirements
PCWG4 addresses a well-documented failure of the clinical trials enterprise: the patients enrolled in trials do not look like the patients who actually have prostate cancer. Black men have the highest incidence and mortality from prostate cancer of any demographic group in the United States, yet remain significantly underrepresented in advanced prostate cancer trials. PCWG4 explicitly calls for investigators to remove unnecessary geographic, logistical, and protocol-imposed barriers to trial participation, to integrate telemedicine options, and to provide financial support for travel and caregiving.
On eligibility, PCWG4 also expands the performance status range recommended for trial inclusion — from the traditional ECOG 0–2 to a broader ECOG 0–3 — to better reflect the real-world population of patients with advanced prostate cancer, including older men with comorbidities who were systematically excluded from earlier trials. This matters because if drugs are approved based on trials enrolling only the healthiest patients, oncologists lack evidence to guide treatment decisions for the sicker patients who most need help.
Change #8 — More Rigorous Molecular Profiling Required
PCWG4 requires that all trial protocols collect comprehensive genetic information at baseline, using CLIA-certified assays for both germline (inherited) and somatic (tumor-specific) mutations. The key targets include:
- DNA repair genes — particularly BRCA1, BRCA2, and ATM — which predict response to PARP inhibitors like olaparib and niraparib
- Androgen receptor (AR) alterations — gene amplification or structural rearrangements that can drive resistance to enzalutamide and abiraterone
- Tumor suppressor genes — including TP53, RB1, and PTEN, associated with more aggressive disease
- Microsatellite instability (MSI) — a marker that predicts response to immunotherapy with pembrolizumab
PCWG4 also calls for rebiopsy of metastatic lesions at the time of disease progression on hormonal therapy — upgraded from a "consider" recommendation in PCWG3 to a formal recommendation in PCWG4 — to capture the biological changes that occur when the cancer evolves under treatment pressure, including neuroendocrine differentiation and lineage plasticity.
What Does PCWG4 Mean for IPCSG Members in 2026?
Clinical trial guidelines may seem remote from day-to-day life with prostate cancer. But PCWG4 will have tangible effects on IPCSG members in the coming years:
- Trial eligibility may broaden. The expanded ECOG performance status criteria and the push to reduce exclusion barriers mean that men who were previously deemed ineligible — because of age, comorbidities, or geography — may qualify for more trials.
- You may not be taken off a promising drug too soon. The NLCB framework and the more sophisticated PSA progression rules mean that experienced oncologists now have formal PCWG4 backing to keep patients on effective therapies when imaging shows limited progression but the patient feels well.
- Your scan results will be interpreted more carefully. PSMA-PET findings in the first eight weeks of therapy will not be used to define progression. Changes in SUV brightness alone will not constitute progression. New lesions — real, high-confidence new sites of disease — remain the standard.
- Your voice matters more formally. Quality-of-life data collected through validated PRO instruments are now required components of trial reporting, not optional add-ons. Regulators at the FDA have signaled they will factor the patient experience into approval decisions.
- Lu-177 PSMA therapy access is expanding. Though not directly a PCWG4 product, the framework's PSMA-PET eligibility guidance directly supports access to 177Lu-PSMA-617 (Pluvicto®), which received FDA approval for PSMA-positive mCRPC in 2022 and an expanded earlier-line indication in March 2025, now permitting use after one ARPI even without prior taxane chemotherapy.
— PCWG4 Discussion Section, JCO, February 2026
Looking Ahead
PCWG4 represents a framework, not a finished product. The authors are explicit that PSMA-PET response criteria, ctDNA thresholds, and CTC benchmarks must be prospectively validated in large phase III trials before they can be accepted by regulatory agencies as surrogates for overall survival. This validation work — now mandated by PCWG4 guidance — will be embedded in the next generation of prostate cancer trials. IPCSG members who enroll in trials over the coming years will be contributing directly to that evidence base.
The bottom line: PCWG4 is a significant step forward for every man living with advanced prostate cancer. It reflects a field that has matured — scientifically, linguistically, and ethically — and is now better equipped to develop and test the therapies that the prostate cancer community has been waiting for.
Questions for your next oncology appointment: Ask your doctor which PCWG4 disease classification applies to you (APMN, APMS, or APMR), whether a PSMA-PET scan is appropriate at your current stage, and whether your PSA trend or imaging findings should trigger a conversation about trial enrollment or therapy adjustment.
Verified Sources and Formal Citations
-
Armstrong AJ, Morris MJ, Abida W, et al. "Trial Design and Objectives for Patients With
Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4."
Journal of Clinical Oncology. 2026;44(13):1249–1265.
DOI: 10.1200/JCO-25-02834.
Full text (open access): https://ascopubs.org/doi/10.1200/JCO-25-02834 -
Prostate Cancer Clinical Trials Consortium (PCCTC). "Prostate Cancer Working Group 4
Unveils Updated Global Standards for Advanced Prostate Cancer Clinical Trials at 2026
ASCO GU Symposium." Press release, February 23, 2026.
https://www.pcctc.org/news/prostate-cancer-working-group-4-unveils-updated-global-standards... -
UroToday. "ASCO GU 2026: Trial Design and Objectives for Prostate Cancer —
Recommendations from PCWG4." Conference Highlights, February 28, 2026.
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Urology Times. "Prostate Cancer Working Group 4 Redefines Trial Frameworks in Era of
PSMA-PET and Precision Oncology." March 30, 2026.
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Busy Clinician?" 2026.
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Mint Medical GmbH. "From PCWG3 to PCWG4: Evolving Standards in Prostate Cancer
Clinical Trials." March 9, 2026.
https://mint-medical.com/news/from-pcwg3-to-pcwg4-evolving-standards-in-prostate-cancer-clinical-trials - Sartor O, de Bono J, Chi KN, et al. "Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer." New England Journal of Medicine. 2021;385(12):1091–1103. DOI: 10.1056/NEJMoa2107322
- Morris MJ, Castellano D, Herrmann K, et al. "177Lu-PSMA-617 versus a Change of Androgen Receptor Pathway Inhibitor Therapy for Taxane-Naive Patients with Progressive Metastatic Castration-Resistant Prostate Cancer (PSMAfore): A Phase 3, Randomised, Controlled Trial." The Lancet. 2024;404:1227–1239. DOI: 10.1016/S0140-6736(24)01651-8
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Memorial Sloan Kettering Cancer Center. "FDA Expands New Treatment for Metastatic
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- Liao Y, Lin Y, Luo B, Shen J. "Prognostic Value of Baseline Circulating Tumor DNA Levels in Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis." Frontiers in Immunology. 2026;17:1691229. DOI: 10.3389/fimmu.2026.1691229
- Conteduca V, Scarpi E, Rossi A, et al. "Changing Metastatic Patterns Associate with Dynamics of Circulating Tumor DNA in Metastatic Castration-Resistant Prostate Cancer." The Oncologist. 2025;30:oyaf107. DOI: 10.1093/oncolo/oyaf107. PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC12082820/
- Knutson TP, Luo B, Kobilka A, et al. "AR Alterations Inform Circulating Tumor DNA Detection in Metastatic Castration Resistant Prostate Cancer Patients." Nature Communications. 2024;15:10612. DOI: 10.1038/s41467-024-54847-1. PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC11634963/
- Hannrich et al. "PSMA-Based Radiopharmaceuticals in Prostate Cancer Theranostics: Imaging, Clinical Advances, and Future Directions." Cancers. 2026;18(2):234. DOI: 10.3390/cancers18020234. PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC12838653/
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CancerNetwork. "FDA Accepts NDA for New Formulation of PSMA PET Injection in
Prostate Cancer." November 8, 2025.
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NCODA Oncology Practice. "Prostate Cancer: Imaging and Therapy Options from an
Oncology Perspective." November 3, 2025.
https://www.ncoda.org/news/prostate-cancer-imaging-and-therapy-options-from-an-oncology-perspective/ - Scher HI, Morris MJ, Stadler WM, et al. "Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations from the Prostate Cancer Clinical Trials Working Group 3." Journal of Clinical Oncology. 2016;34(12):1402–1418. DOI: 10.1200/JCO.2015.64.2702 [Prior guidance document, for comparison]
All URLs verified as of May 13, 2026. The PCWG4 paper (source 1) is published under a Creative Commons Attribution 4.0 License and is freely available at the ASCO Publications website. Members are encouraged to share the link with family members, caregivers, and primary care physicians.
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