OncoMatch/Clinical Trials/NCT05393791
Phase II Randomised Controlled Trial of Patient-specific Adaptive vs. Continuous Abiraterone or eNZalutamide in mCRPC
Is NCT05393791 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Abiraterone acetate and Enzalutamide for prostatic neoplasms, castration-resistant.
Treatment: Abiraterone acetate · Enzalutamide — Hormone tablets, abiraterone (Zytiga®) and enzalutamide (Xtandi®) are approved to treat advanced prostate cancer. However, even if these drugs are helpful, their effectiveness usually diminishes over time. Small pilot studies have indicated that using hormone tablets sparingly, for just long enough to control the cancer, followed by a break in treatment and restarting them later, seems to improve how long hormone tablets can control the cancer. This study aims to find out if this pause/restart strategy is better than taking hormone tablets every day continuously. The study will include 168 people with metastatic castrate resistant prostate cancer in the Netherlands and Australia. Patients will be randomly 1:1 assigned between the control group and the experimental group. In the control group, patients will take the treatment with AA/ENZ every day until the prostate cancer doesn't respond anymore to the treatment. In the experimental group, patients will start with daily AA/ENZ until the PSA has declined for \>50%. The treatment will then be paused and monthly PSA measurements will be performed. The treatment will be re-initiated when the PSA has increased to the level of before starting treatment. The treatment will be continued daily until the PSA has again dropped for \>50%. This pause/restart cycle will be repeated until the prostate cancer doesn't respond anymore to the treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen deprivation therapy (GnRH analogue, bilateral orchiectomy) — ongoing
Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e. surgical or medical castration with testosterone at screening ≤1.7 nmol/L (<0.5 ng/mL)); patients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial
Cannot have received: CYP17 inhibitor (ketoconazole)
Prior treatments with CYP17 inhibitors (e.g. ketoconazole)
Cannot have received: novel androgen receptor inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Prior treatments with novel androgen receptor inhibitors (e.g. abiraterone, apalutamide, darolutamide or enzalutamide)
Lab requirements
Blood counts
absolute neutrophil count > 1,500/μL (> 1.5*10^9/L); platelet count > 100,000/μL (> 100*10^9/L), haemoglobin > 90 g/L; albumin > 30 g/L
Kidney function
creatinine < 175 μmol/L
Liver function
total bilirubin < 1.5 times ULN, ALT or AST < 3 times ULN
Adequate organ function: absolute neutrophil count > 1,500/μL (> 1.5*10^9/L); platelet count > 100,000/μL (> 100*10^9/L), haemoglobin > 90 g/L; total bilirubin < 1.5 times ULN, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 times ULN; creatinine < 175 μmol/L; albumin > 30 g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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