Clinical trial · Observational
Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)
Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer
NCT06491056CI-TRIAL-00078626ProAMFocalrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal Therapy for Prostate Cancer | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Focal Therapy for Prostate Cancer
- description
- Patients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of \<75% of the prostate gland.
- interventionNames
- Device: Focal Therapy for Prostate Cancer
Primary outcomes (10)
- measure
- Overall Survival
- timeFrame
- 20 years
- description
- Living at 20 years after treatment
- measure
- Metastasis-Free Survival
- timeFrame
- 20 years
- description
- Metastasis Free at 20 years after treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDOng 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. PMID 36083229
- BACKGROUNDTay 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. PMID 28349978
- RESULTTan 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. PMID 36895163
- RESULTTay 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. PMID 28654336