Focal or Radical Therapy: a Lesion-based Molecular Evaluation in Prostate Cancer

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

Focal therapy (FT) is a new approach to treating localized prostate cancer. Instead of treating the entire prostate, it targets only the cancerous areas while preserving healthy tissue. This helps reduce side effects like urinary, sexual, and bowel problems. In a prospective observational expansion of a phase II clinical trial (ProAMFocal), 80% of patients with small, localized prostate cancers treated with FT had no cancer recurrence at one year, and 70% at 3 years after treatment. The investigators studied the genetic makeup of each cancer, and found that certain genetic markers and cancer subtypes were better at predicting recurrence than standard clinical measures. Based on this, the investigators are launching the FLAME-PC trial. In this study, all patients who qualify for FT will first undergo genetic profiling of their cancer. Patients with favorable profiles (low risk based on genetic markers) will receive FT, while those with high-risk profiles will be advised to undergo standard treatments like prostate removal or radiation. The investigators current main goal is to test if genetic profiling can help us better select patients for FT. They believe that patients chosen using this method will have low recurrence rates (\<10%) compared to those in their previous study (20-30%). FLAME-PC aims to show that personalized treatment based on genetic profiling can improve outcomes for prostate cancer patients, offering effective cancer control with fewer side effects.

Key facts

Study ID

NCT07282808

Run by

Singapore General Hospital

People needed

130

Starts

2026-01-01

Expected to finish

2048-09-01

Last updated by the study team

2026-01-08

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Singapore General Hospital — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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