Active Cancer Mental Health

Increasing compliance with Active surveillance: A randomised trial evaluating the role of Finasteride

In plain English

AI plain-English summary

A 550-patient trial will test whether the drug finasteride can keep men with low-risk prostate cancer from dropping out of Active Surveillance—the strategy of monitoring the tumour rather than treating it immediately. Many men diagnosed with low or intermediate-risk prostate cancer choose Active Surveillance to avoid the side effects of surgery or radiation. Yet a significant number eventually abandon this approach, opting for treatment they may not need. The problem is that anxiety, rising PSA levels, or ambiguous biopsy results can push patients toward unnecessary intervention. This trial asks whether finasteride—a drug that shrinks the prostate and lowers PSA—can reduce those triggers and improve adherence. If finasteride proves effective, it could become a simple, low-cost tool to help thousands of men stay on Active Surveillance, sparing them from overtreatment and its lifelong consequences. The trial follows patients for an average of four years, tracking adherence, need for re-biopsy, and MRI findings. Success would shift clinical practice by adding a pharmacological support to a monitoring strategy that currently relies entirely on patient and clinician resolve.

View original technical description
The study is a randomised controlled CTIMP in men with newly diagnosed low/intermediate risk localised prostate cancer. We will randomise 550 patients to Active Surveillance with or without once daily finasteride. Patients will receive finasteride for 2 years and will be followed up for an average of 4 years. Active surveillance will include PSA, re-biopsy and MRI as per usual NHS care. The primary outcome is adherence with Active Surveillance in both arms.

View the original record at the funder ↗

Researchers

James Catto (EPMC Awardee)

Related Research

Grants with similar aims, by meaning.

A randomised controlled trial of regular MRI scans compared to standard care in patients with prostate cancer managed using active surveillance
CRUK/07/037: ProStart: A Pilot Study for a PhaseIII Clinical Trials in Patients with favourable risk prostate cancer comparing active surveillance therapy against radical treatment
A randomised controlled trial to assess screening for prostate cancer compared to current standard of care
Targeted drug intervention in men at risk of progression on active surveillance for early prostate cancer: A randomised trial – Therapeutics in Active Prostate cancer Surveillance (TAPS02).
Targeted drug intervention in men at risk of progression on active surveillance for early prostate cancer: A randomised trial – Therapeutics in Active Prostate cancer Surveillance (TAPS02)

Original classification

Research Grant

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