What is apalutamide studying for prostate cancer?

Apalutamide is being studied to evaluate its impact on prostate cancer progression in men under active surveillance. This trial aims to understand if short-term androgen deprivation therapy can affect tumor growth and patient outcomes. The research is sponsored by Cambridge University Hospitals NHS Foundation Trust.

Who may be eligible for this prostate cancer clinical trial?

Men aged 18 or older with prostate cancer who have chosen active surveillance may be eligible. Participants must have specific MRI findings and laboratory results within defined limits. Those with prior androgen deprivation therapy use or certain health conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Age: 18Years +

MALE

ID05191680

Randomized Phase 2 Trial of Apalutamide Therapy in Men on Active Surveillance for Early Prostate Cancer

Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2025-06-20

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the use of short-term androgen deprivation therapy with apalutamide Erleada in men on active surveillance for early prostate cancer. This phase 2, randomized, multicenter, double-blind, placebo-controlled trial aims to evaluate the effects of apalutamide on tumor progression in men at risk while under active surveillance. The study is sponsored by Cambridge University Hospitals NHS Foundation Trust and focuses on men with MRI-detectable prostate lesions and specific biopsy findings who are managing their cancer without immediate treatment. Participants will be randomly assigned to one of three groups one group will receive apalutamide 240 mg daily for up to 6 months another group will receive apalutamide 240 mg daily for 3 months followed by placebo for 3 months and the third group will receive placebo daily for 6 months. The study uses tablets taken orally and includes a quadruple-blind design to compare these treatments. The treatment phase is followed by a monitoring period to assess outcomes. During the trial, participants will undergo MRI scans to measure tumor volume 12 months after treatment ends. Researchers will also collect patient-reported outcomes on quality of life and track any adverse events from consent through 30 to 45 days post-treatment. Longer-term outcomes include progression rates over 3 years after treatment completion. The study involves regular clinical and laboratory assessments to monitor safety and effectiveness, with overall participation lasting several years to capture these measures.

CONDITIONS

Brief Title

TherApeutics in Early ProState Cancer (TAPS02)

Who Can Participate

Age: 18Years +

MALE

Eligibility Criteria

You may qualify if you...

Have given written informed consent to participate.
Be aged 18 or over.
Have an Eastern Cooperative Oncology Group (ECOG) status 0-2.
Have selected active surveillance as a management option.
Have an MRI detectable lesion with an M score of 653 using Likert scale OR PI-RADS (version 2.1) reporting criteria. If M score is 3 then lesion size (single or combined) of 6510mm.
Have prostate cancer from a combination of image guided targeted + systematic biopsies and MRI lesion and biopsy are concordant for a prostate cancer diagnosis.
Not anticipated to require bladder outlet surgery during IMP treatment or for up to 12 months of follow-up.
Meet all of the following clinical laboratory assessment criteria:
Haemoglobin 659.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomisation.
Platelet count 65100 x 10�b9/L independent of transfusion and/or growth factors within 3 months prior to randomisation.
Absolute neutrophil count (ANC) 651.0 x 10�b9/L within 21 days prior to randomisation.
Serum albumin 653.0 g/dL within 21 days prior to randomisation.
Glomerular filtration rate (GFR) 6530 ml/min AND Serum creatinine 643 times the ULN (calculated by Cockcroft and Gault equation using actual body weight) within 21 days prior to randomisation.
Serum potassium 653.5 mmol/L within 21 days prior to randomisation.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 642.5 �d7 ULN AND Serum total bilirubin 641.5 �d7 ULN within 21 days prior to randomisation (Note: In patients with confirmed Gilbert's syndrome, if total bilirubin is >1.5 �d7 ULN, measure direct and indirect bilirubin and if direct bilirubin is 641.5 �d7 ULN, patient may be eligible in consultation with their physician).
Have prostate cancer with any one or more of the following:
CPG2 (based on Grade Group 2 on histology)
CPG1 (based on Grade Group 1 on histology) with PSA high density (PSAd >0.15) and LIKERT or PI-RADS 4/5 lesion (individual or combined) of 6510mm size.
CPG1 with PSA high density (PSAd >0.15) and 6550% biopsy core involvement (number of positive cores/all cores taken) with target biopsies counted as one if LIKERT or PI-RADS 3 lesion

You will not qualify if you...

Contraindications to apalutamide or its excipients.
Pelvic metalwork interfering with MRI prostate interpretation.
Any prior or concurrent use of androgen deprivation therapy (ADT) or androgen receptor targeting agents (not including established and continued use of 5-ARIs for urinary symptoms).
Systemic therapy for prostate cancer.
Inability for patient to have prostate MRI scan.
Concurrent involvement in a Clinical Trial of Investigational Medicinal Product (CTIMP); participation in an observational trial/studies is acceptable.
Seizure or known condition that may pre-dispose to seizure (including but not limited to the following within 1 year prior to randomisation: prior stroke, transient ischemic attack, loss of consciousness, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing oedema or mass effect).
Medications known to lower the seizure threshold or cause seizures must be discontinued or substituted at least 28 days prior to randomisation.
In the opinion of investigator, patient is at increased risk of falls or fractures.
Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomisation. Cardiovascular risk factors should be optimised i.e. hypertension, diabetes, dyslipidaemia.
Uncontrolled hypertension (SBP 65160 mmHg or DBP 6590 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
Gastrointestinal disorder affecting absorption.
Medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g., quinidine, disopyramide) or class III (e.g., amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics (e.g. haloperidol). Alternative therapy, for the prohibited medication known to prolong the QTc, may be inistigated. A minimum washout for the discontinued medication of 654 half-lives is required prior to starting IMP.
Symptoms suggestive of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).

Research Team

Elizabeth Young

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Randomized Phase 2 Trial of Apalutamide Therapy in Men on Active Surveillance for Early Prostate Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria