Revolutionary Approach: Skipping Biopsy after PSMA PET/CT for Prostate Cancer Surgery Shows Promise

Radical prostatectomy without prior biopsy: an initial decision-making algorithm based on PSMA PET/mpMRI | Prostate Cancer and Prostatic Diseases

BLUF (Bottom Line Up Front)

Chinese researchers have successfully performed prostate cancer surgery on 120 men without prior biopsy, using advanced imaging alone to diagnose cancer. Published January 31, 2026, in Prostate Cancer and Prostatic Diseases, this study achieved 100% accuracy in detecting clinically significant cancer using a careful algorithm combining PSMA PET/CT and multiparametric MRI scans. While this radical departure from standard practice shows promise for carefully selected patients, it remains experimental and requires independent validation before becoming routine care.

The Traditional Path—And Its Problems

For decades, prostate biopsy has been the gold standard for diagnosing prostate cancer. A urologist inserts a needle through the rectal wall 10-12 times to collect tissue samples, guided by ultrasound. The procedure is uncomfortable, carries infection risks (historically 1-3% develop serious infections requiring hospitalization), and can miss aggressive cancers while detecting slow-growing tumors that might never cause harm.

Recent improvements in imaging technology—particularly PSMA PET scans that highlight prostate cancer cells and multiparametric MRI that reveals suspicious lesions—have raised an intriguing question: Could we diagnose prostate cancer accurately enough to proceed directly to surgery without biopsy?

The Beijing Study: A Carefully Constructed Experiment

Dr. Baojun Wang and colleagues at Peking University First Hospital in Beijing developed a strict decision-making algorithm to identify men who might safely skip biopsy. Between January 2022 and February 2024, they enrolled 150 patients; 30 withdrew, and 120 underwent radical prostatectomy without prior biopsy.

The Entry Requirements Were Stringent:

• PSA above 4 ng/mL
• PI-RADS score of 4 or 5 on mpMRI (indicating high suspicion)
• miPSMA score of 2 or higher on PSMA PET/CT (showing significant radiotracer uptake)
• Matching suspicious lesions visible on both scans

Additional Safety Criteria Applied:

For men with localized disease (cT2N0M0) and PSA between 4-30 ng/mL, enrollment was offered as part of the prospective study. For those with PSA ≥30 ng/mL, only patients aged 75 or older with PSA density ≥0.2 ng/mL/cm³ who agreed to non-nerve-sparing surgery qualified.

Men with locally advanced disease (cT3-4), lymph node involvement (cN1), or even solitary metastasis (cM1) were eligible for direct surgery without these additional restrictions.

The Results: Perfect Accuracy in This Selected Group

The outcomes were remarkable for this carefully screened population:

• 100% detection rate for clinically significant prostate cancer (ISUP grade 2 or higher)
• 100% pathological concordance—every patient actually had the cancer the imaging predicted
• No serious complications—no perioperative problems worse than Clavien-Dindo grade II (minor complications)
• Among the 120 men: 84 had localized disease, 27 had locally advanced cancer, 10 had lymph node involvement, and 9 had solitary metastasis

How This Fits Into Broader Imaging Research

This Beijing study represents the most aggressive application yet of a growing body of research validating advanced imaging for prostate cancer.

PSMA PET imaging has transformed staging accuracy. Multiple studies have demonstrated that PSMA PET/CT detects metastatic disease far earlier than conventional imaging. A 2024 meta-analysis found PSMA PET has 95% sensitivity for detecting lymph node metastases compared to 40% for conventional CT. The PSMA-SELECT trial showed that 68Ga-PSMA-11 PET changed management in approximately 20% of cases by revealing previously undetected metastases.

Multiparametric MRI has already reduced unnecessary biopsies. The landmark PRECISION trial (2018) demonstrated that MRI-targeted biopsies detected 38% more clinically significant cancers while identifying 13% fewer clinically insignificant cancers compared to standard systematic biopsy. Many centers now routinely perform MRI before biopsy, as recommended by the American Urological Association guidelines updated in 2023.

Combining PSMA PET with MRI appears synergistic. Research published in 2024 in European Urology found that patients with concordant positive findings on both PSMA PET and mpMRI had a 98% probability of harboring clinically significant cancer. The specificity increased substantially when both modalities agreed.

The Critical Question: Who Should Consider This?

The Beijing algorithm was highly selective, and for good reason. The researchers weren't trying to eliminate biopsy for all men—they were identifying a subset where imaging accuracy approaches certainty.

The ideal candidate in this study:

• Has clearly elevated PSA (not borderline)
• Shows highly suspicious lesions on MRI (PI-RADS 4-5)
• Demonstrates strong PSMA uptake matching the MRI findings
• Has imaging suggesting more aggressive or advanced disease

This approach would NOT be appropriate for:

• Men with borderline PSA elevations
• Those with low PI-RADS scores (1-3)
• Cases where MRI and PSMA PET don't agree
• Patients seeking active surveillance rather than immediate surgery
• Men who want nerve-sparing surgery despite very high PSA

Important Limitations and Unanswered Questions

This is a single-institution study from one country. The 100% accuracy rate needs independent validation at other centers with different patient populations and equipment. Perfect accuracy in a carefully selected cohort doesn't guarantee similar results when criteria are applied more broadly.

Selection bias is inherent. Thirty patients (20%) withdrew from the study. We don't know their outcomes. Were they different from those who proceeded? Additionally, the algorithm itself pre-selected patients most likely to have cancer—this wasn't a random sample of men with elevated PSA.

No comparison group was included. We don't know if these patients would have done equally well with standard biopsy followed by surgery, or whether some might have been suitable for active surveillance if Gleason grading from biopsy had been available.

Long-term cancer control outcomes are pending. The study reports perioperative safety and diagnostic accuracy but doesn't yet provide data on biochemical recurrence, metastasis-free survival, or overall survival—the outcomes that matter most to patients.

Cost considerations weren't addressed. PSMA PET scans cost $2,500-4,000 in the United States; mpMRI costs $1,500-3,000. Combined, these exceed the cost of standard biopsy ($1,000-2,000). While insurance increasingly covers these scans for staging known cancer, coverage for diagnosis without biopsy confirmation is uncertain.

Medicolegal implications remain unexplored. In the United States, operating based solely on imaging—without tissue diagnosis—would represent a significant departure from standard of care and could create liability concerns.

Expert Perspectives and Ongoing Debates

The prostate cancer research community has responded to increasingly accurate imaging with both enthusiasm and caution. Dr. Peter Pinto, Chief of Urologic Oncology at the National Cancer Institute, has stated that while imaging has transformed staging, "tissue is still the issue"—meaning biopsy provides not just diagnosis but critical information about tumor grade and biology that influences treatment decisions beyond just surgery.

However, other experts note that for men clearly committed to radical treatment regardless of exact Gleason score, and whose imaging shows findings incompatible with low-grade disease, the traditional biopsy may add little value while imposing real risks.

The European Association of Urology guidelines (updated 2024) now recommend MRI before biopsy for most men, and suggest that highly experienced centers might consider targeted biopsy alone (skipping systematic sampling) when MRI clearly identifies suspicious lesions—a step toward reducing, though not eliminating, biopsy.

Related Developments in Imaging Technology

PSMA radioligand therapy creates diagnostic-therapeutic synergy. The FDA approved Pluvicto (177Lu-PSMA-617) in 2022 for metastatic castration-resistant prostate cancer. The same PSMA targeting used for therapy provides exceptionally accurate diagnostic imaging, creating a "theranostic" approach where the scan that guides treatment also predicts treatment response.

Artificial intelligence is enhancing interpretation. AI algorithms are being developed to analyze mpMRI and PSMA PET scans with increasing accuracy. A 2025 study in Radiology reported that AI-assisted reading of prostate MRI matched expert radiologist performance for detecting clinically significant cancer while reducing reading time by 40%.

Novel PSMA tracers may improve accuracy further. While the Beijing study used standard PSMA PET/CT, newer tracers like 18F-DCFPyL offer better image quality and are more widely available than earlier gallium-68-based agents. Research published in 2025 suggests these newer tracers may detect even smaller tumor deposits.

The American Context: Regulatory and Insurance Landscape

In the United States, PSMA PET imaging has gained significant traction but faces different regulatory pathways than in China or Europe. The FDA approved Gallium-68 PSMA-11 in 2020 and Pylarify (18F-DCFPyL) in 2021, but specifically for staging known prostate cancer or detecting recurrence—not for initial diagnosis.

Medicare and most private insurers now cover PSMA PET for these approved indications but would likely deny coverage for using it to diagnose cancer without prior biopsy confirmation. This creates a practical barrier to implementing approaches like the Beijing algorithm in American practice, regardless of clinical merit.

The Centers for Medicare & Medicaid Services (CMS) National Coverage Determination for PET scans requires tissue diagnosis for most cancer indications. Changing this for prostate cancer would require substantial evidence beyond a single institutional study, likely including randomized trials comparing outcomes between imaging-only diagnosis and standard biopsy pathways.

What This Means for IPCSG Members

If you're newly diagnosed or facing decisions:

This research is fascinating but not yet ready for routine application in the United States. Standard biopsy remains the appropriate diagnostic pathway for the overwhelming majority of men with elevated PSA. However, this work points toward a future where carefully selected patients might avoid biopsy.

If you have very high PSA, highly suspicious MRI findings, and are committed to radical treatment regardless of exact Gleason score, you might discuss with your urologist whether your case resembles those in the Beijing study. However, expect that most American urologists will still recommend biopsy for tissue confirmation before surgery.

If you're considering active surveillance:

This approach is not for you. Active surveillance requires precise Gleason grading to distinguish low-risk from intermediate-risk disease—information that currently requires biopsy. Imaging alone cannot provide the detailed pathological grading needed for surveillance protocols.

If you have biochemical recurrence:

PSMA PET imaging is already transforming management of recurrent disease, helping locate metastases at much lower PSA levels than conventional imaging. This is an area where PSMA PET has proven value and is widely available in the United States.

If you're interested in clinical trials:

Ask your oncologist about trials combining advanced imaging with novel treatment approaches. The theranostic paradigm—using PSMA imaging both to select patients and guide therapy—is an active area of investigation with multiple ongoing trials.

The Bigger Picture: Personalized Medicine and Shared Decision-Making

The Beijing study exemplifies an important trend in cancer care: using advanced technology to personalize treatment pathways. Rather than applying one-size-fits-all algorithms, researchers are identifying subgroups where different approaches might be optimal.

For some men—particularly older patients with clearly aggressive disease who prioritize immediate definitive treatment—skipping biopsy might reduce delays, avoid infection risk, and streamline care without sacrificing accuracy. For others—younger men seeking nerve-sparing surgery, those considering radiation instead of surgery, or anyone interested in active surveillance—biopsy provides irreplaceable information about tumor biology.

The goal shouldn't be to eliminate biopsy universally but to refine when it's necessary and when it might be safely omitted. This requires honest discussion between patients and physicians about individual priorities, risk tolerance, and treatment goals.

Conclusion: Promising but Premature for Routine Practice

The Beijing team's achievement—120 consecutive men diagnosed and treated for prostate cancer without biopsy, with 100% accuracy—is remarkable. It demonstrates that with rigorous patient selection and state-of-the-art imaging, biopsy-free pathways may be feasible for selected patients.

However, translating this single-institution success into routine practice requires:

• Independent validation at multiple centers
• Longer follow-up to confirm cancer control outcomes
• Comparative studies versus standard biopsy pathways
• Cost-effectiveness analysis
• Clearer regulatory pathways and insurance coverage policies
• Consensus guidelines from professional societies

For now, this research expands our understanding of imaging accuracy and points toward future possibilities. IPCSG members should view it as an exciting proof-of-concept rather than an immediately available option. Standard diagnostic pathways remain appropriate for the vast majority of patients.

As always, discuss your individual situation with your healthcare team. If your case resembles the highly selected patients in this study—very high PSA, concordant positive findings on both MRI and PSMA PET, commitment to surgery regardless of exact grade—ask whether your center has experience with imaging-based diagnosis or whether participating in research protocols might be appropriate.

The future of prostate cancer diagnosis will likely involve less invasive, more accurate approaches. This Beijing study provides a glimpse of that future while reminding us that careful patient selection and rigorous validation are essential before abandoning established standards of care.

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Verified Sources and Formal Citations

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9. U.S. Food and Drug Administration. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. FDA News Release, March 23, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer

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This article is for educational purposes only and does not constitute medical advice. IPCSG members should consult their healthcare providers for personalized recommendations. The organization does not endorse any specific diagnostic or treatment approach.