A major new clinical trial is set to investigate whether the drug finasteride can help men with early-stage prostate cancer remain on active surveillance protocols rather than opting for more aggressive treatments prematurely.
The FINESSE trial (Finasteride in Active Surveillance Study) is designed as a prospective, open-label, phase 3 study that will randomize 550 men with low or intermediate-risk prostate cancer to either standard active surveillance alone or active surveillance plus finasteride 5mg daily for two years.
"Active surveillance has emerged as a crucial strategy to reduce overtreatment of prostate cancer, but maintaining long-term patient compliance remains challenging," explains Dr. Marcus Cumberbatch from Sheffield Teaching Hospitals NHS Foundation Trust, a lead investigator on the trial. "We hope to determine if finasteride can help address this important clinical need."
Study Design and Patient Population
The trial will recruit men aged 50-75 years across up to eight clinical sites. Participants will be stratified by age and prostate cancer risk level during randomization to ensure balanced groups. The active surveillance protocol includes regular PSA testing, MRI scans, and optional repeat biopsies at 3 years or if imaging suggests disease progression.
Patients assigned to the intervention arm will receive finasteride 5mg once daily for two years in addition to standard monitoring. Additional imaging or biopsies may be performed based on biochemical or clinical indicators of progression.
Comprehensive Outcome Assessment
The primary endpoint of the study is adherence to active surveillance protocols. Secondary outcomes will evaluate:
- Rates and patterns of disease progression
- Types of treatments received for both cancer and benign prostatic enlargement
- Overall and prostate cancer-specific mortality
- Health-related quality of life measures
- Patient and healthcare provider perspectives on this management approach
An independent expert panel, blinded to treatment allocation, will review all cases where active surveillance is discontinued or disease progression occurs. Additionally, trial pathologists and radiologists will conduct blinded reviews of representative cases to ensure consistent assessment.
Clinical Impact and Future Implications
The study addresses a critical challenge in prostate cancer management, as approximately 40% of men are diagnosed with localized low or intermediate-risk disease suitable for active surveillance. However, many patients ultimately undergo radical treatment despite having relatively indolent disease.
"By evaluating finasteride's potential role in active surveillance, we hope to identify ways to help more men safely avoid or delay unnecessary aggressive treatments while maintaining confidence in their cancer management strategy," notes Dr. James Catto, another key investigator.
The trial has received all necessary regulatory approvals, including from the Health Research Authority and South-Central Oxford Research Ethics Committee. Results will be published in publicly accessible scientific journals to ensure widespread dissemination of findings to healthcare providers and researchers.
Follow-up will continue for 3-5 years of active monitoring, followed by passive registry-based tracking for up to 10 years, providing valuable long-term data on this management approach.
