Focal or Radical Therapy: a Lesion-based Molecular Evaluation in Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21+
SponsorSingapore General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Prostate Adenocarcinoma
Grade Group 2-4
MRI lesion size ≤3ml for single lesions ≤1.5ml for 2 lesions
no gross EPE
Disqualifiers
Grade Group 5 cancer
gross EPE
multifocal (>2) clinically significant prostate cancer
unablatable location (very apical, basal tumors, or otherwise determined by procedurist).
Trial design
Design model
Parallel
Treatments tested in this trial
Molecular Evaluation for Risk of Recurrence after FT
Diagnostic testLow 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
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: Focal Therapy, Low Transcriptomic Risk CohortExperimental treatment 1 intervention
Group B: Radical Therapy, High Transcriptomic Risk CohortExperimental treatment 1 intervention
Group C: Focal Therapy, Unselected for Transcriptomic Risk of Recurrence (Historical)No intervention 0 interventions
Trial outcomes
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
Time frame
12 months after FTSecondary outcomes
1
1 year Post-Focal Therapy Infield clinically significant cancer recurrence
Recurrence of clinically significant cancer (≥GG2) within the treated area at 12 months MRI and biopsy
Time frame
12 months after FT2
1 year Post-Focal Therapy Outfield clinically significant cancer recurrence
Recurrence of clinically significant cancer (≥GG2) outside the treated area at 12 months MRI and biopsy
Time frame
12 months after FT3
Failure-free survival
salvage treatment, metastatic cancer, systemic treatment, or transition to watchful waiting.
Time frame
Over 20 years following enrolment4
Metastatic Cancer Free Survival
Free from metastatic cancer on imaging, and/or PSA ≥50 ng/ml
Time frame
Over 20 years following enrolmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Singapore General Hospital
Lead sponsor
Veracyte, Inc.
Collaborator
Source ClinicalTrials.gov