NCT05191680 TherApeutics in Early ProState Cancer (TAPS02)
| NCT ID | NCT05191680 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-04-24 |
| Primary Completion | 2029-10 |
Trial Parameters
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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.
Eligibility Criteria
INCLUSION CRITERIA 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
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