Actively Recruiting

Phase Not Applicable
Age: 21Years +
MALE
NCT07282808

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

Led by Singapore General Hospital · Updated on 2026-01-08

130

Participants Needed

1

Research Sites

1182 weeks

Total Duration

On this page

Sponsors

S

Singapore General Hospital

Lead Sponsor

V

Veracyte, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Prostate Adenocarcinoma
  • Grade Group 2-4
  • MRI lesion size �3ml for single lesions or �1.5ml for 2 lesions
  • No gross extraprostatic extension (EPE)
  • Cancer assessed to be completely ablatable with margin using focal therapy
Not Eligible

You will not qualify if you...

  • Grade Group 5 cancer
  • Gross extraprostatic extension (EPE)
  • More than 2 clinically significant prostate cancer lesions (multifocal)
  • Cancer in locations deemed unablatable (very apical, basal tumors, or as determined by procedurist)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Singapore General Hospital

Singapore, Singapore

Actively Recruiting

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Research Team

K

Kae Jack Tay, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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