Alpha-Particle Therapy Shows Superior Cancer-Killing Power

Supply Breakthrough Accelerates Path to Patients

BLUF (Bottom Line Up Front)

New research demonstrates that actinium-225 alpha-particle therapy kills prostate cancer cells far more effectively than current lutetium-177 treatments in laboratory studies. Multiple human clinical trials are already underway showing promising safety and response rates. Critically, a supply revolution in 2024-2025 has eliminated the isotope scarcity that once constrained development. However, even the most advanced actinium-225 therapies remain 3-5 years from potential FDA approval. Men with advanced prostate cancer facing treatment decisions today should proceed with proven therapies like Pluvicto rather than waiting, while staying informed about emerging trials.

The Physics of More Powerful Cancer Treatment

For men with metastatic castration-resistant prostate cancer—the deadliest form of the disease that no longer responds to hormone therapy—a fundamental change in radiation therapy may offer new hope. The difference comes down to physics: alpha particles versus beta particles.

Researchers at the University of Wisconsin-Madison recently demonstrated that actinium-225, which emits alpha particles, achieved significantly better tumor control and extended survival compared to lutetium-177, a beta-emitter, in mouse models of prostate cancer. The study, led by Dr. Carolina Ferreira and colleagues, tested both isotopes attached to the same targeting molecule (NM600) to directly compare their effectiveness.

The distinction matters enormously. Beta particles travel several millimeters through tissue, spreading their energy over that distance, while alpha particles travel only 50-80 micrometers but release far more concentrated energy in that compact space. This concentrated power creates what radiation oncologists call higher "relative biological effectiveness"—alpha particles cause more severe, irreparable DNA damage that cancer cells cannot survive.

Remarkably, the Wisconsin researchers needed approximately 1,000 times less radioactive material when using actinium-225 to achieve superior results compared to lutetium-177, demonstrating the extraordinary potency of alpha radiation.

Today's Standard: Understanding Pluvicto

To appreciate where actinium-225 fits, understanding the current FDA-approved treatment is essential. Pluvicto (lutetium-177 PSMA-617) received FDA approval in March 2022 based on the VISION trial, which demonstrated that adding Pluvicto to standard care reduced the risk of death by 38% compared to standard care alone.

Median overall survival was 15.3 months with Pluvicto plus standard care versus 11.3 months with standard care alone—a four-month improvement. The treatment involves six doses given every six weeks. Common side effects include fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation, with laboratory tests showing decreased blood cell counts.

Pluvicto is approved for patients with PSMA-positive metastatic castration-resistant prostate cancer who have received at least one androgen receptor pathway inhibitor and one or two taxane-based chemotherapy regimens. While the four-month survival improvement represents meaningful progress, it also illustrates why researchers are pursuing more powerful approaches.

Human Trials Already Underway

Unlike the Wisconsin research which remains in mice, actinium-225 is already being tested in human patients through multiple clinical trials worldwide.

Real-World Evidence: The WARMTH Act Study

The largest real-world evidence comes from the WARMTH Act study, a retrospective analysis of 488 men with metastatic castration-resistant prostate cancer treated at seven centers across Australia, India, Germany, and South Africa. These were heavily pre-treated patients—all had received prior therapies including chemotherapy, hormone treatments, and in many cases, lutetium-177 PSMA therapy.

Results showed a median overall survival of 15.5 months, with patients achieving PSA declines of 50% or greater demonstrating 11.6-month median progression-free survival. These survival times are notable given how extensively pre-treated these patients were—they had exhausted most other options. The most common side effect was dry mouth (xerostomia), affecting 68% of patients, while severe bone marrow and kidney toxicity remained relatively uncommon.

The European Commission's Joint Research Centre, which collaborated on developing actinium-225-PSMA-617, reports that more than 300 South African patients have been successfully treated through their collaboration with Steve Biko Academic Hospital in Pretoria.

The Combination Strategy: Alpha Plus Beta Together

Dr. Scott Tagawa at Weill Cornell Medical Center is pioneering a novel approach: combining both alpha and beta radiation in a single treatment regimen. His Phase I trial (NCT04886986) gives patients actinium-225-J591 (an antibody carrying alpha radiation) immediately followed by lutetium-177-PSMA I&T (a small molecule carrying beta radiation).

The strategy is elegant—large antibody molecules and small targeting compounds behave differently in the body. Antibodies circulate longer and may penetrate tumors differently than small molecules, which diffuse more rapidly and clear faster from normal tissues. By delivering both types of radiation simultaneously, the treatment might achieve more complete tumor coverage.

Among 18 heavily pre-treated patients (two-thirds had prior chemotherapy, two-thirds had tried at least two hormone therapies), safety results were encouraging. Only two dose-limiting toxicities occurred—both involving low platelet counts. Other side effects remained mostly mild.

The effectiveness signals were striking: 94% of patients experienced PSA declines, with 61% achieving at least 50% reduction. Imaging showed actual tumor shrinkage including at least one complete response where a liver metastasis disappeared entirely on scans. Five out of seven patients with unfavorable circulating tumor cell counts improved to favorable status.

More recent data presented at the 2025 American Urological Association meeting compared outcomes between patients receiving actinium-225 alone versus combination therapy, showing PSA50 response rates of 48% for single-agent and 57% for combination therapy.

Additional Trials Now Enrolling

Beyond Tagawa's combination trial, several other actinium-225 studies are actively recruiting:

The McGill University Health Centre in Montreal enrolled the first patients in April 2024 for a Phase 1 trial testing actinium-225 PSMA therapy, becoming the first site worldwide to launch this particular study, led by Dr. Ramy Saleh.

The ACCEL trial (NCT06229366) is evaluating actinium-225-PSMA-62 in both early-stage hormone-sensitive disease and late-stage castration-resistant prostate cancer, with Phase II comparing the treatment to standard care using radiographic progression-free survival as the primary endpoint.

Full-Life Technologies received FDA fast track designation in July 2024 for their investigational agent 225Ac-FL-020, with a Phase 1 trial launched to assess safety and preliminary anti-tumor activity. Fast track designation enables more frequent FDA engagement and potential for accelerated approval if results warrant.

A recent systematic review and meta-analysis examining actinium-225 PSMA therapy across multiple studies found that 65% of patients achieved at least 50% PSA reduction—higher than the 49% rate reported for lutetium-177 therapies.

The Supply Revolution: From Bottleneck to Abundance

For years, actinium-225's promise remained largely theoretical—not because the science didn't work, but because there simply wasn't enough isotope. That constraint shattered in 2024-2025.

The Old Reality

Oak Ridge National Laboratory previously produced the majority of the world's actinium-225 supply by extracting it from thorium-229, yielding only about 1 curie annually—insufficient even for large-scale clinical trials, let alone widespread clinical use. If the FDA approves multiple actinium-225 drugs, demand could rise to more than 50,000 millicuries per year, but the traditional process could only create two to four percent of that amount.

Multiple Producers Now Online

A remarkable transformation occurred as commercial-scale producers brought new capacity online:

TerraPower Isotopes (October 2024): Announced commercial-scale production with weekly production runs, providing sustained access to highly pure actinium-225 now being used in multiple drug developers' radiopharmaceuticals in human clinical trials globally.

Cardinal Health (December 2024): Announced weekly production through its Center for Theranostics Advancement in Indianapolis, becoming the first to provide cGMP actinium-225 globally at scale, in collaboration with TerraPower Isotopes.

SpectronRx (October 2025): Commenced mass production using a proprietary accelerator-based method, producing at commercial scale sufficient to meet rising global demand. The company operates over 250,000 square feet of facilities with more than 50 hot cells, employing 220 people across five U.S. and European locations, already delivering actinium-225 products across 29 countries to more than 31 pharmaceutical and biotech companies.

Eckert & Ziegler (December 2024): Celebrated successful start of production using innovative cyclotron-based methods to generate actinium-225 from radium-226, with GMP-grade material expected in the first half of 2025.

IONETIX Corporation (June 2024): Announced successful production at its dedicated alpha isotope manufacturing facility in Lansing, Michigan, using proprietary cyclotron accelerator technology. In June 2025, IONETIX announced a strategic partnership with Dutch company AlfaRim Medical to accelerate scale-up production and establish sustainable, commercial-scale supply.

NorthStar Medical Radioisotopes (Expected 2025): Is completing a 30,000 square foot facility dedicated to commercial-scale production using a dedicated IBA Rhodotron electron accelerator, with initial production and drug master file submission both expected in 2025.

Regulatory Infrastructure in Place

The FDA accepted Type II Drug Master File submissions for both accelerator-produced actinium-225 (January 2020) and thorium-229 decay product actinium-225 (January 2021) from Oak Ridge National Laboratory. These filings provide the regulatory foundation enabling drug developers to reference approved manufacturing processes in their applications.

In a significant milestone, the DOE Isotope Program announced it will supply accelerator-produced actinium-225 to a U.S. company for the first U.S. clinical trial scheduled to begin in summer 2025—the first trial to rely on accelerator-produced material for human patient care.

What This Means

Scientists estimate they can now provide more than 20 times as much actinium-225 to medical researchers as previously possible, with ongoing upgrades aimed at reaching commercial-scale production levels. Supply is no longer the limiting factor—the pace of clinical development and regulatory approval now determines when these treatments reach patients.

Realistic Timeline: When Will Patients Have Access?

Understanding the timeline is crucial for men making treatment decisions today.

For New Agents Like Wisconsin's NM600

The Wisconsin research, while promising, has only been tested in mice. Even with accelerated development, the pathway typically requires:

  • Additional preclinical work (1-2 years): Optimizing formulation, additional animal studies, toxicology
  • Phase I safety trials (1-2 years): First tests in humans, dose-finding
  • Phase II efficacy studies (2-3 years): Determining if it works, optimal patient selection
  • Phase III comparison trials (3-4 years): Large studies comparing to standard treatments
  • FDA review (1+ year): Agency evaluation of all data

Realistic timeline: 8-13 years from today, assuming no significant setbacks.

For Agents Already in Human Trials

The actinium-225 PSMA agents currently in Phase I/II trials are further along but still early-stage:

  • Complete Phase I (1-2 years): Establish safety, optimal dosing
  • Phase II studies (2-3 years): Confirm effectiveness signals
  • Phase III trials (3-4 years): Large comparative studies required for approval
  • FDA review (1+ year): Regulatory evaluation

Realistic timeline: 5-8 years for the most advanced candidates, potentially faster if Phase II results are exceptional and FDA grants breakthrough therapy designation.

The Accelerated Scenario

In the most optimistic case, if Phase II results are extraordinary and the treatment receives breakthrough therapy designation (which Full-Life Technologies' 225Ac-FL-020 has already received fast track designation), the timeline might compress to 3-5 years. This would require:

  • Outstanding efficacy data
  • Clear safety profile
  • Unmet medical need (which exists)
  • FDA willingness to accept smaller Phase III trials or potentially approve based on strong Phase II data

However, even this optimistic scenario means men facing treatment decisions in 2025 will likely not have FDA-approved actinium-225 therapy available before 2028-2030.

Making Treatment Decisions Today

For men currently facing advanced prostate cancer, several considerations are critical:

Don't Wait for Future Treatments

Metastatic castration-resistant prostate cancer progresses. Delaying established therapies while waiting for experimental options could mean:

  • Missing the window when treatment would be most effective
  • Losing eligibility for trials or approved treatments due to declining health
  • Experiencing complications that earlier treatment might have prevented
  • Disease progression that reduces life expectancy more than any future treatment could extend it

Current Trial Access Is Possible

Some actinium-225 trials are enrolling now. Men should discuss with their oncologists:

  • Whether they qualify for available studies (check clinicaltrials.gov)
  • Whether they live near trial sites or can travel to major academic medical centers
  • Whether trial eligibility criteria match their disease characteristics
  • Whether enrolling in a trial would delay access to proven treatments

Important: Some current trials specifically enroll patients who have already received lutetium-177 therapy, meaning Pluvicto now doesn't necessarily preclude actinium-225 trials later.

Sequential Treatment Strategy

Receiving Pluvicto now doesn't necessarily prevent actinium-225 therapy later if it becomes available. The key factors would be:

  • Overall health status at that future time
  • Bone marrow function (both treatments affect blood cells)
  • Whether cancer still expresses PSMA or other targetable markers
  • Specific trial eligibility criteria

The Complete Treatment Landscape

Beyond radioligand therapy, treatment options include:

  • Newer hormone therapies (enzalutamide, abiraterone, darolutamide)
  • Chemotherapy (docetaxel, cabazitaxel)
  • Immunotherapy approaches (for mismatch repair deficient cancers)
  • Targeted therapies for specific mutations (PARP inhibitors for BRCA mutations)
  • Radium-223 for bone metastases
  • Clinical trials of various novel agents
  • Supportive care and pain management

A comprehensive oncology team can help sequence these treatments optimally based on individual disease characteristics.

Looking Ahead: The Promise and the Patience

The progression from beta to alpha radiation in targeted therapy may ultimately prove as significant as the initial development of radioligand therapy itself. The physics supporting alpha radiation's superior cancer-killing ability is sound. The early human data show encouraging activity with manageable toxicity. Production capacity has expanded dramatically.

Multiple Phase 3 trials are evaluating lutetium-177 PSMA therapy in earlier disease stages, including PSMAfore, SPLASH, and ECLIPSE studies, testing whether radioligand therapy works better when given earlier in the disease course. If successful, these trials will establish that earlier intervention with even beta-emitters improves outcomes—strengthening the rationale for eventually testing more powerful alpha-emitters earlier as well.

Yet translating scientific promise into approved treatments accessible to patients requires methodical clinical development. Each trial provides crucial data on optimal dosing, patient selection, treatment sequencing, and long-term outcomes. There are no shortcuts through this process that don't risk patient safety or result in ineffective treatments reaching the market.

The Bottom Line for Patients

Men facing advanced prostate cancer today should:

  1. Proceed with proven treatments like Pluvicto when indicated—don't wait years for actinium-225 therapies that remain in development

  2. Stay informed about clinical trials and discuss eligibility with oncologists—some actinium-225 trials are enrolling now

  3. Maintain realistic timelines—even the most advanced actinium-225 agents are likely 3-5 years from FDA approval, with many 5-8 years away

  4. Understand sequential treatment is possible—receiving current therapies now doesn't necessarily preclude future actinium-225 treatment if it becomes available and you need additional therapy

  5. Focus on the complete strategy—radioligand therapy is one weapon among many; comprehensive care involves sequencing multiple treatment modalities

For the prostate cancer community, these developments represent substantial hope tempered by necessary patience. The supply revolution of 2024-2025 removed a critical obstacle that once threatened to keep these treatments perpetually experimental. Now the work of rigorous clinical testing can proceed without isotope scarcity constraining progress.

Alpha-particle therapy may offer men with advanced prostate cancer a more powerful weapon against a challenging disease. But that promise must be validated through careful clinical trials before it can benefit patients. In the meantime, proven treatments exist that extend life and preserve quality of life—and those should not be delayed while waiting for the next generation of therapies to complete their journey from laboratory to clinic.

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PSMA-Targeted Therapies for Prostate Cancer: Move Treatment Earlier in Disease Course

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  Interactive Graphic PSMA-Targeted Therapies for Prostate Cancer: Move Treatment Earlier in Disease Course Landmark FDA approval expands access to radioligand therapy while new research explores next-generation treatments By [Your Name] for the IPCSG Newsletter The landscape of prostate cancer treatment has undergone a seismic shift in recent months, with groundbreaking advances in prostate-specific membrane antigen (PSMA)-targeted therapies offering new hope to patients across different stages of the disease. Most significantly, the FDA's March 2025 expansion of Pluvicto (lutetium-177-PSMA-617) approval now allows treatment before chemotherapy, potentially tripling the number of eligible patients. Major FDA Approval Expands Treatment Access On March 28, 2025, the FDA approved a crucial expansion of Pluvicto's indication, allowing its use in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen recepto...
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