OncoMatch/Clinical Trials/NCT05191680
TherApeutics in Early ProState Cancer (TAPS02)
Is NCT05191680 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Apalutamide Oral Tablet [Erleada] for prostate cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Prostate Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT05191680 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior androgen deprivation therapy, systemic therapy disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages