Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)

NCT ID: NCT06491056

Last Updated: 2024-07-08

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-06

Study Completion Date

2048-05-06

Brief Summary

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

Detailed Description

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

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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Cryotherapy High Intensity Focused Ultrasound (HIFU) Irreversible Electroporation (IRE) Nanoknife HIFU Cryoablation Laser Microwave ablation

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Kae Jack Tay, MBBS

Role: CONTACT

Facility Contacts

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Kae Jack Tay, MBBS

Role: primary

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.

Reference Type BACKGROUND
PMID: 36083229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28349978 (View on PubMed)

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.

Reference Type RESULT
PMID: 36895163 (View on PubMed)

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.

Reference Type RESULT
PMID: 28654336 (View on PubMed)

Other Identifiers

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CIRB 2023/2055

Identifier Type: -

Identifier Source: org_study_id

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