Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)
NCT ID: NCT06491056
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-05-06
2048-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Focal Therapy for Prostate Cancer
Ablation of \<75% of the prostate gland for limited volume prostate cancer
Interventions
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Focal Therapy for Prostate Cancer
Ablation of \<75% of the prostate gland for limited volume prostate cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
85 Years
MALE
No
Sponsors
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National Medical Research Council (NMRC), Singapore
OTHER_GOV
Singapore General Hospital
OTHER
Responsible Party
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Locations
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Singapore General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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CIRB 2023/2055
Identifier Type: -
Identifier Source: org_study_id
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