Lesion-based molecular decision for focal versus radical prostate treatment
Official title: Focal or Radical Therapy: a Lesion-based Molecular Evaluation in Prostate Cancer
Run by Singapore General Hospital · NCT07282808 · Data updated 2026-11-12
This trial will test whether tumor genetic profiling can help decide if men with localized Grade Group 2–4 prostate cancer should get focal therapy or be advised to have radical treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | Men only |
| Enrollment | 130 (estimated) |
| Sponsor | Singapore General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Singapore) |
| Status | Recruiting |
| Started | January 2026 |
| Main results expected | September 2028 |
| Study ends | September 2048 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT07282808 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with prostate adenocarcinoma Grade Group 2–4, up to two MRI-visible lesions of specified small volume (≤3 ml for one lesion or ≤1.5 ml each for two lesions), no gross extraprostatic extension, and judged completely ablatable by focal therapy are ideal candidates.
✕Probably not a fit
Men with Grade Group 5 disease, gross extraprostatic extension, more than two clinically significant lesions, or tumors in unablatable locations are unlikely to benefit from focal therapy and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants who meet focal-therapy anatomical criteria will have molecular profiling (genomic classifier and subtype) performed on their tumor lesion before treatment. Men whose lesions show a favorable molecular profile will be offered focal therapy, while those with high-risk molecular features will be advised to undergo standard radical treatment. The approach builds on prior prospective data showing higher recurrence after focal therapy in lesions with high genomic risk scores and luminal proliferative subtype. The trial is being run at Singapore General Hospital in collaboration with Veracyte and focuses on small, ablatable lesions defined by MRI and biopsy mapping.
Why it matters
Potential benefit: If successful, using lesion-level molecular profiling could reduce cancer recurrence after focal therapy and spare eligible men the side effects of whole-gland treatment.
How similar studies have gone: Prior prospective phase II/expansion data (ProAMFocal) showed about 80% freedom from recurrence at 1 year and identified genomic classifier scores and luminal proliferative subtyping as predictors of recurrence, supporting this molecular-guided approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prostate Adenocarcinoma * Grade Group 2-4 * MRI lesion size ≤3ml for single lesions ≤1.5ml for 2 lesions * no gross EPE * assessed to be completely ablatable with margin with focal therapy. Exclusion Criteria: * Grade Group 5 cancer * gross EPE * multifocal (\>2) clinically significant prostate cancer * unablatable location (very apical, basal tumors, or otherwise determined by procedurist).
Where it's running
-
Singapore General Hospital
Singapore, Singapore Recruiting
Study contacts
- Principal investigator: Kae Jack Tay, MBBS — Singapore General Hospital
- Study coordinator: Kae Jack Tay, MBBS
- Email: tay.kae.jack@singhealth.com.sg
- Phone: +65 63214639
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.