TherApeutics in Early ProState Cancer (TAPS02)

NCT05191680 | Recruiting Phase 2 DMC

• 2 other identifiers: TAPS022021-006106-75
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Prostate Cancer

Keywords

active surveillance; prostate cancer; therapeutics in prostate cancer; apalutamide; short term androgen deprivation therapy; androgen receptor inhibitor

Outcome Measures

Primary Outcomes (1)

• MRI defined tumour volume

  To determine whether there is a reduction in MRI defined tumour volume at 12 months post treatment in at least 50% of the treated cohort in either treatment arm compared to the baseline measurement.

  12 months after end of treatment

Secondary Outcomes (5)

• Reported adverse events

  Reported from the point of obtaining informed consent until the safety FU visit (30-45 days post-treatment)

• Patient-reported outcomes EORTC QLQ-C30

  Cumulative until 12 months after end of treatment

• Patient-reported outcomes EQ-5D-5L

  Cumulative until 12 months after end of treatment

• Cumulative rate of progression (any progression)

  3 years after completion of treatment

• Cumulative rate of progression to any prostate cancer treatment (for any cause)

  3 years after completion of treatment

Study Arms (3)

Apalutamide 6 months

EXPERIMENTAL

Participants will receive apalutamide 240 mg (4 x 60 mg tablets) orally once a day for up to 6 months.

Drug: Apalutamide Oral Tablet [Erleada]

Apalutamide 3 months + Placebo 3 months

EXPERIMENTAL

Participants will receive apalutamide 240mg (4 x 60 mg tablets) orally once a day for up to 3 months followed by placebo to match apalutamide (4 tablets) orally once a day for up to 3 months.

Drug: Apalutamide Oral Tablet [Erleada]; Drug: Placebo

Placebo 6 months

PLACEBO COMPARATOR

Participants will receive placebo to match apalutamide (4 tablets) orally once a day for up to 6 months.

Drug: Placebo

Interventions

Apalutamide Oral Tablet [Erleada] DRUG

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

Also known as: Erleada

Apalutamide 3 months + Placebo 3 months; Apalutamide 6 months

Placebo DRUG

Placebo to match apalutamide

Apalutamide 3 months + Placebo 3 months; Placebo 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in the trial the patient must:
• 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 ≥ 3 using Likert scale OR PI-RADS (version 2.1) reporting criteria. If M score is 3 then lesion size (single or combined) of ≥10mm.
• 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 ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomisation.
• Platelet count ≥ 100 x 109/L independent of transfusion and/or growth factors within 3 months prior to randomisation.
• Absolute neutrophil count (ANC) ≥ 1.0 x 109/L within 21 days prior to randomisation.
• Serum albumin ≥ 3.0 g/dL within 21 days prior to randomisation.
• Glomerular filtration rate (GFR) ≥ 30 ml/min AND Serum creatinine ≤ 3 times the ULN (calculated by Cockcroft and Gault equation using actual body weight) within 21 days prior to randomisation.
• Serum potassium ≥3.5 mmol/L within 21 days prior to randomisation.

You may not qualify if:

• 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 ≥ 160 mmHg or DBP ≥ 90 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 ≥ 4 half-lives is required prior to starting IMP.
• Symptoms suggestive of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator
• Janssen-Cilag Ltd.: collaborator

Study Sites (6)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

RECRUITING

West Suffolk Hospital

Bury St Edmunds, IP33 2QZ, United Kingdom

RECRUITING

Darent Valley Hospital

Dartford, DA2 8DA, United Kingdom

RECRUITING

St Bartholomew's Hospital

London, E1 1FR, United Kingdom

RECRUITING

The Royal Marsden Hospital - Chelsea

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Vincent J Gnanapragasam, Prof.

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Young

CONTACT

01223 256364; cuh.taps02trial@nhs.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Honorary Consultant Urologist

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 13, 2022
• Study Start: April 24, 2023
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 20, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)