OncoMatch/Clinical Trials/NCT05191680

TherApeutics in Early ProState Cancer (TAPS02)

Is NCT05191680 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Apalutamide Oral Tablet [Erleada] for prostate cancer.

Phase 2RecruitingCambridge University Hospitals NHS Foundation TrustNCT05191680Data as of May 2026

Treatment: Apalutamide Oral Tablet [Erleada] — 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.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: androgen deprivation therapy

Exception: established and continued use of 5-ARIs for urinary symptoms

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)

Cannot have received: systemic therapy

Systemic therapy for prostate cancer

Lab requirements

Blood counts

Haemoglobin ≥ 9.0 g/dL, Platelet count ≥ 100 x 10^9/L, ANC ≥ 1.0 x 10^9/L within 21 days prior to randomisation

Kidney function

GFR ≥ 30 ml/min AND Serum creatinine ≤ 3 times the ULN (Cockcroft and Gault equation using actual body weight) within 21 days prior to randomisation

Liver function

AST or ALT ≤2.5 × ULN AND Serum total bilirubin ≤1.5 × ULN within 21 days prior to randomisation (Gilbert's syndrome exception: if direct bilirubin is ≤1.5 × ULN, patient may be eligible)

Meet all of the following clinical laboratory assessment criteria: Haemoglobin ≥ 9.0 g/dL, Platelet count ≥ 100 x 10^9/L, ANC ≥ 1.0 x 10^9/L, Serum albumin ≥ 3.0 g/dL, GFR ≥ 30 ml/min AND Serum creatinine ≤ 3 times the ULN, Serum potassium ≥3.5 mmol/L, AST or ALT ≤2.5 × ULN AND Serum total bilirubin ≤1.5 × ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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