Clinical trial NCT06491056: Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)
Official title: Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: focal therapy
cryotherapy
high intensity focused ultrasound
irreversible electroporation
focal laser ablation
Microwave ablation
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2024-07-08
Enrollment: 500
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with limited volume prostate cancer undergoing focal therapy (FT).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: 20 years
measure: Metastasis-Free Survival
timeFrame: 20 years
measure: Progression-Free Survival
timeFrame: 20 years
measure: Short-term Clinically Significant Prostate Cancer Recurrence
timeFrame: 18 months
measure: Intermediate-term Clinically Significant Prostate Cancer Recurrence
timeFrame: 5 years
measure: Sexual Function
timeFrame: 12 months
measure: Urinary Function
timeFrame: 12 months
measure: Bowel Function
timeFrame: 12 months
measure: Radical Intervention-free Survival
timeFrame: 5 years
measure: Treatment Failure-free Survival
timeFrame: 5 years
Secondary outcomes:
measure: Intervention-Free Survival
timeFrame: 20 years
measure: Radical Intervention-Free Survival
timeFrame: 20 years
measure: Failure-Free Survival
timeFrame: 10 years
measure: Failure-Free Survival
timeFrame: 20 years
Other outcomes:
measure: Inter-modality Comparison of short-term Oncological Outcomes
timeFrame: 12 months
measure: Inter-modality Comparison of Conversion to Radical Treatment Rates
timeFrame: 10 years
measure: Inter-modality Comparison of Treatment Failure Rates
timeFrame: 10 years
measure: Inter-modality Comparison of Metastasis Rates
timeFrame: 10 years
measure: Inter-modality Comparison of Sexual Function Outcomes
timeFrame: 12 months
measure: Inter-modality Comparison of Urinary Function Outcomes
timeFrame: 12 months
measure: Inter-modality Comparison of Bowel Function Outcomes
timeFrame: 12 months
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
citation: Ong S, Chen K, Grummet J, Yaxley J, Scheltema MJ, Stricker P, Tay KJ, Lawrentschuk N. Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus? BJU Int. 2023 Jan;131(1):20-31. doi: 10.1111/bju.15883. Epub 2022 Sep 27.
citation: Tay KJ, Scheltema MJ, Ahmed HU, Barret E, Coleman JA, Dominguez-Escrig J, Ghai S, Huang J, Jones JS, Klotz LH, Robertson CN, Sanchez-Salas R, Scionti S, Sivaraman A, de la Rosette J, Polascik TJ. Patient selection for prostate focal therapy in the era of active surveillance: an International Delphi Consensus Project. Prostate Cancer Prostatic Dis. 2017 Sep;20(3):294-299. doi: 10.1038/pcan.2017.8. Epub 2017 Mar 28.
citation: Tan YG, Law YM, Ngo NT, Khor LY, Tan PH, Ong EHW, Yuen JSP, Ho HSS, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Chua MLK, Polascik TJ, Tay KJ. Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study. Prostate. 2023 Jun;83(8):781-791. doi: 10.1002/pros.24517. Epub 2023 Mar 9.
citation: Tay KJ, Cheng CWS, Lau WKO, Khoo J, Thng CH, Kwek JW. Focal Therapy for Prostate Cancer with In-Bore MR-guided Focused Ultrasound: Two-Year Follow-up of a Phase I Trial-Complications and Functional Outcomes. Radiology. 2017 Nov;285(2):620-628. doi: 10.1148/radiol.2017161650. Epub 2017 Jun 26.