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

NCT07282808 | Recruiting

• 1 other identifier: 2025-1018
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

focal therapy; decipher; cryotherapy; irreversible electroporation; hifu; biomarker

Outcome Measures

Primary Outcomes (1)

• 1-year Post-Focal Therapy (FT) clinically significant cancer recurrence

  Recurrence of clinically significant prostate cancer infield or outfield at 12-month MRI and biopsy after focal therapy

  12 months after FT

Secondary Outcomes (6)

• 1 year Post-Focal Therapy Infield clinically significant cancer recurrence

  12 months after FT

• 1 year Post-Focal Therapy Outfield clinically significant cancer recurrence

  12 months after FT

• Failure-free survival

  Over 20 years following enrolment

• Metastatic Cancer Free Survival

  Over 20 years following enrolment

• Cancer-specific Survival

  Over 20 years following enrolment

Study Arms (3)

Focal Therapy, Low Transcriptomic Risk Cohort

EXPERIMENTAL

Low Transcriptomic Risk for recurrence after FT: Decipher GC Score \<0.5; OR GC 0.5-0.85 and non PSC-LP subtype

Diagnostic Test: Molecular Evaluation for Risk of Recurrence after FT

Radical Therapy, High Transcriptomic Risk Cohort

EXPERIMENTAL

High Transcriptomic Risk for recurrence after FT: Decipher GC 0.5-0.85 and PSC-LP subtype, or GC \>0.85

Diagnostic Test: Molecular Evaluation for Risk of Recurrence after FT

Focal Therapy, Unselected for Transcriptomic Risk of Recurrence (Historical)

NO INTERVENTION

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).

Interventions

Molecular Evaluation for Risk of Recurrence after FT DIAGNOSTIC_TEST

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

Also known as: Decipher GC score, Transcriptomic Signature

Focal Therapy, Low Transcriptomic Risk Cohort; Radical Therapy, High Transcriptomic Risk Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Singapore General Hospital: lead
• Veracyte, Inc.: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

RECRUITING

Related Publications (1)

• Tay KJ, Hong BH, Ong EHW, Tan KM, Pacho GC, Wong SJ, Tan YG, Law YM, Ngo NT, Tan PH, Yuen JSP, Ho HSS, Chen K, Peng J, Foo CWT, Sam XX, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Polascik TJ, Liu Y, Proudfoot J, Davicioni E, Khor LY, Chua MLK. Transcriptomic predictors of prostate cancer recurrence following focal cryotherapy: a pooled analysis of phase II trial and prospective cohort data. J Natl Cancer Cent. 2025 May 29;5(5):515-523. doi: 10.1016/j.jncc.2025.04.002. eCollection 2025 Oct.

  PMID: 41111925 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kae Jack Tay, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kae Jack Tay, MBBS

CONTACT

+65 63214639; tay.kae.jack@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 15, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2048
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 7 years from end of study
• Access Criteria: via the principle investigator

Locations

SG (1)