RecruitingPhase 2NCT05191680

TherApeutics in Early ProState Cancer (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).


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

90 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing apalutamide — a drug that blocks male hormones from fueling prostate cancer — in men with early-stage prostate cancer who have chosen active surveillance (watchful waiting) rather than immediate treatment. The goal is to see if a short course of this drug can slow or stop disease progression. **You may be eligible if...** - You are 18 or older with early-stage, low-to-intermediate risk prostate cancer - You have chosen active surveillance as your management plan - You have an MRI-detectable lesion and confirmed cancer from a targeted biopsy - You are in reasonably good health (ECOG 0–2) with adequate organ function **You may NOT be eligible if...** - You have had any prior hormone therapy or androgen receptor-blocking treatment for prostate cancer - You have a history of seizures, recent stroke, brain lesions, or conditions that may trigger seizures - You have significant heart problems, including recent heart attack, severe angina, or blood clots within 6 months - You have uncontrolled high blood pressure - You are taking medications known to cause dangerous heart rhythm problems (QT-prolonging drugs) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApalutamide Oral Tablet [Erleada]

Apalutamide is a selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.

DRUGPlacebo

Placebo to match apalutamide


Locations(6)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Southmead Hospital

Bristol, United Kingdom

West Suffolk Hospital

Bury St Edmunds, United Kingdom

Darent Valley Hospital

Dartford, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

The Royal Marsden Hospital - Chelsea

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05191680


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