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

NCT07282808 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Molecular Evaluation for Risk of Recurrence after FT

Low Risk - Decipher GC \<0.5, OR GC 0.5-0.85 and non-PSC-LP subtype High Risk - Decipher GC 0.5-0.85 and PSC-LP subtype, OR GC\>0.85

Sponsors & Collaborators

  • Veracyte, Inc.

    collaborator INDUSTRY

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Kae Jack Tay, MBBS · Singapore General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-09-30
Completion
2048-09-30

Countries

  • Singapore

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282808 on ClinicalTrials.gov