Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: Focal Therapy for Prostate Cancer

• Registration Number: NCT06491056
• Lead Sponsor: Singapore General Hospital

Brief Summary

This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia

Detailed Description

Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.

Study Timeline

• Study Start: 2023-05-06
• Study First Submitted: 2023-07-03
• Status Verified: 2024-06
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2028-05-06
• Study Completion: 2048-05-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

• Prostate Adenocarcinoma
• Maximum Gleason score 4+4
• Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)
• Maximum Prostate Specific Antigen (PSA) level 15 ng/dl
• Maximum clinical stage T2c
• American Society of Anesthesiologist Criteria 2 or less

Exclusion Criteria

• Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Focal Therapy for Prostate Cancer	Focal Therapy for Prostate Cancer	Patients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of \<75% of the prostate gland.

Primary Outcome Measures

Name	Time	Method
Radical Intervention-free Survival	5 years	Free of Radical Prostatectomy or Radiation at 5 years
Overall Survival	20 years	Living at 20 years after treatment
Metastasis-Free Survival	20 years	Metastasis Free at 20 years after treatment
Progression-Free Survival	20 years	Progression-Free (Local or Systemic) at 20 years after treatment
Sexual Function	12 months	Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months
Urinary Function	12 months	Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Short-term Clinically Significant Prostate Cancer Recurrence	18 months	12-18 month infield and outfield recurrence rate
Intermediate-term Clinically Significant Prostate Cancer Recurrence	5 years	5 year infield and outfield recurrence rate
Bowel Function	12 months	Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Treatment Failure-free Survival	5 years	Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years

Secondary Outcome Measures

Name	Time	Method
Failure-Free Survival	20 years	Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years
Intervention-Free Survival	20 years	Intervention (Focal or Whole Gland/ Radical)-free at 20 years
Radical Intervention-Free Survival	20 years	Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore