Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal) (ProAMFocal)

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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Focal Therapy for Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Kae Jack Tay, MBBS; Phone Number: 63214693; Email: tay.kae.jack@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 169856
    • Recruiting
    • Singapore General Hospital
    • Contact: Kae Jack Tay, MBBS; Phone Number: 63214693; Email: tay.kae.jack@singhealth.com.sg
    • Principal Investigator: Kae Jack Tay, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with limited volume prostate cancer undergoing focal therapy (FT).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Focal Therapy for Prostate Cancer; Ablation of <75% of the prostate gland for limited volume prostate cancer; Other Names: Cryoablation; HIFU; Cryotherapy; Microwave ablation; Nanoknife; Laser; High Intensity Focused Ultrasound (HIFU); Irreversible Electroporation (IRE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Living at 20 years after treatment	20 years
Metastasis-Free Survival	Metastasis Free at 20 years after treatment	20 years
Progression-Free Survival	Progression-Free (Local or Systemic) at 20 years after treatment	20 years
Short-term Clinically Significant Prostate Cancer Recurrence	12-18 month infield and outfield recurrence rate	18 months
Intermediate-term Clinically Significant Prostate Cancer Recurrence	5 year infield and outfield recurrence rate	5 years
Sexual Function	Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months	12 months
Urinary Function	Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months	12 months
Bowel Function	Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months	12 months
Radical Intervention-free Survival	Free of Radical Prostatectomy or Radiation at 5 years	5 years
Treatment Failure-free Survival	Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention-Free Survival	Intervention (Focal or Whole Gland/ Radical)-free at 20 years	20 years
Radical Intervention-Free Survival	Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years	20 years
Failure-Free Survival	Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years	10 years
Failure-Free Survival	Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years	20 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-modality Comparison of short-term Oncological Outcomes	Comparison of 12-month infield and outfield recurrence rates between different focal therapy modalities	12 months
Inter-modality Comparison of Conversion to Radical Treatment Rates	Comparison of 10 year conversion to radical treatment (Radical Prostatecomy or Radiation) between different modalities	10 years
Inter-modality Comparison of Treatment Failure Rates	Comparison of 10 year failure (Radical Prostatectomy or Radiation or Hormonal Therapy or transition to Watchful Waiting) between different modalities	10 years
Inter-modality Comparison of Metastasis Rates	Comparison of 10 year metastasis-rate between different modalities	10 years
Inter-modality Comparison of Sexual Function Outcomes	Comparing mean change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.	12 months
Inter-modality Comparison of Urinary Function Outcomes	Comparing mean change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.	12 months
Inter-modality Comparison of Bowel Function Outcomes	Comparing mean change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.	12 months

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: National Medical Research Council (NMRC), Singapore

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2023
• Primary Completion (Estimated): May 6, 2028
• Study Completion (Estimated): May 6, 2048

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: cryotherapy; irreversible electroporation; Microwave ablation; high intensity focused ultrasound; focal therapy; focal laser ablation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CIRB 2023/2055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes