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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 21
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
Singapore General Hospital
RECRUITING
Singapore
Contact Information
Primary
Kae Jack Tay, MBBS
tay.kae.jack@singhealth.com.sg
+65 63214639
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2048-09
Participants
Target number of participants: 130
Treatments
Experimental: Focal Therapy, Low Transcriptomic Risk Cohort
Low Transcriptomic Risk for recurrence after FT: Decipher GC Score \<0.5; OR GC 0.5-0.85 and non PSC-LP subtype
Experimental: Radical Therapy, High Transcriptomic Risk Cohort
High Transcriptomic Risk for recurrence after FT: Decipher GC 0.5-0.85 and PSC-LP subtype, or GC \>0.85
No_intervention: Focal Therapy, Unselected for Transcriptomic Risk of Recurrence (Historical)
From ProAMFocal (NCT06491056): Focal Therapy performed on all comers (no molecular evaluation) based on clinical criteria only (PSA ≤15 ng/ml, GG2-4, MRI lesion size ≤3ml for single and ≤1.5ml for two lesions, no gross EPE, determined to be completely ablatable).
Related Therapeutic Areas
Sponsors
Collaborators: Veracyte, Inc.
Leads: Singapore General Hospital

This content was sourced from clinicaltrials.gov

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