Protocol for a randomised phase 3 trial evaluating the role of Finasteride in Active Surveillance for men with low and intermediate-risk prostate cancer: the FINESSE Study

BackgroundProstate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cance...

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Veröffentlicht in:BMJ open Jg. 15; H. 2; S. e096431
Hauptverfasser: Cumberbatch, Marcus, North, Bernard, Kealy, Roseann, Smith, Samuel, Hubbard, Rachel, Kennish, Steven, Bhattrai, Selina, Cross, William, Chahal, Rohit, Bryant, Richard, Lamb, Alastair D, Dooldeniya, Mohantha, Faulkner, Simon, Sasieni, Peter, Catto, James
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England British Medical Journal Publishing Group 11.02.2025
BMJ Publishing Group LTD
BMJ Publishing Group
Schlagworte:
5-alpha Reductase Inhibitors - therapeutic use
Aged
Antigens
Biopsy
Clinical Trials, Phase III as Topic
Consent
Disease Progression
Finasteride - administration & dosage
Finasteride - therapeutic use
Humans
Magnetic Resonance Imaging
Male
Medical ethics
Medical research
Middle Aged
Mortality
Patients
Prospective Studies
Prostate
Prostate cancer
Prostate-Specific Antigen - blood
Prostatic Neoplasms
Prostatic Neoplasms - drug therapy
Prostatic Neoplasms - pathology
Protocol
Quality of Life
Randomized Controlled Trials as Topic
SURGERY
Surveillance
Urological tumours
Urology
Watchful Waiting - methods
SURGERY
Prostatic Neoplasms
Urological tumours
Prostate
ISSN:2044-6055, 2044-6055
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Zusammenfassung:BackgroundProstate cancer (PCa) is the most common male malignancy in the western world. Many men (40%) are diagnosed with localised low or intermediate-risk PCa, which is suitable for active surveillance (AS). AS affords careful monitoring to identify changes in otherwise non-life-threatening cancers. While AS reduces overtreatment (and quality of life impact), long-term compliance can be poor, with many men undergoing radical treatment after starting AS.Methods and analysisFinasteride in Active Surveillance for men with low and intermediate-risk prostate cancer (FINESSE) is a prospective, open-label, two-arm, phase 3 trial, in which men with low or intermediate PCa are randomised (1:1) to receive AS with or without finasteride (5 mg once a day for 2 years). Randomisation is stratified by age and PCa risk. AS includes regular prostate-specific antigen testing, MRI scans and the offer of repeat biopsy (at 3 years, or if imaging suggests progression). Additional MRI scans and/or biopsies will be performed for biochemical or clinical indications. We aim to recruit 550 men (aged 50 to 75 years) from up to eight sites. Active outpatient follow-up will be for 3–5 years (depending on date recruited), followed by passive registry-based follow-up for up to 10 years. Primary outcome is adherence to AS. Secondary outcomes include rates and type of disease progression, treatments received (for PCa and benign prostatic enlargement), overall and PCa-specific mortality, an understanding of patients/professionals views of this approach and health-related quality of life. An external panel of experts blinded to allocation will review all AS cessation and progression events. Trial pathologist’s and radiologist’s, blinded to allocation, will review representative cases. Analysis is Intention to Treat.Ethics and disseminationThe study received Health Research Authority and South-Central Oxford Research Ethics Committee (14/12/2021: 21/SC/0349) and CTA/MHRA (29/12/2021: 21304/0274/001–0001) approvals. Results will be made available to providers and researchers via publicly accessible scientific journals.Trial registration number ISRCTN16867955
Bibliographie:Protocol
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MC has received speaker fees from Ipsen and Pfizer. JC has received reimbursement for consultancy from Astra Zeneca, BMS, Ipsen, Janssen and Roche, speaker fees from BMS, Ipsen, MSD, Nucleix and Roche, honoraria for membership of advisory boards from Astra Zeneca, Ferring, Roche and Janssen, and research funding from Roche. PS is a paid member of the Scientific Advisory Board of GRAIL and the medical advisory board of NSV. The remaining authors declare no potential conflicts of interest.
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2024-096431