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Recruiting NCT06491056

Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)

— Observational Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focal Therapy for Prostate Cancer.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 40 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer

Overview

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.

Interventions

  • Device Focal Therapy for Prostate Cancer
    Ablation of \<75% of the prostate gland for limited volume prostate cancer

Primary outcome measures

  • Overall Survival [Time frame: 20 years]
  • Metastasis-Free Survival [Time frame: 20 years]
  • Progression-Free Survival [Time frame: 20 years]
  • Short-term Clinically Significant Prostate Cancer Recurrence [Time frame: 18 months]
  • Intermediate-term Clinically Significant Prostate Cancer Recurrence [Time frame: 5 years]
  • Sexual Function [Time frame: 12 months]
  • Urinary Function [Time frame: 12 months]
  • Bowel Function [Time frame: 12 months]
  • Radical Intervention-free Survival [Time frame: 5 years]
  • Treatment Failure-free Survival [Time frame: 5 years]
Secondary outcome measures (4)
  • Intervention-Free Survival [Time frame: 20 years]
  • Radical Intervention-Free Survival [Time frame: 20 years]
  • Failure-Free Survival [Time frame: 10 years]
  • Failure-Free Survival [Time frame: 20 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Singapore · 1 center
  • Singapore General Hospital — Singapore

Publications

  • 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. PMID 36083229
  • 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. PMID 28349978
  • 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. PMID 36895163
  • 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. PMID 28654336

Identifiers

NCT: NCT06491056 · CIRB 2023/2055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗