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A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) (22-008)

The purpose of this study is to evaluate the efficacy and safety of capivasertib in addition to docetaxel versus placebo plus docetaxel in patients with mCRPC.

If you choose to take part in this trial, you must agree to come to all study visits, take your study medication as instructed and complete all questionnaires and procedures., including but not limited to examinations, vital signs, height and weight, Echocardiogram, skeletal scan, laboratory tests, ECG, tumor assessment. (CT/MRI, Bone scan)

Monika Joshi
Kathleen Rizzo - at

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patient must be => 18 years of age at the time of signing the informed consent
Histologically-confirmed prostate adenocarcinoma
Metastatic disease documented prior to randomisation by clear evidence of => 1 bone lesion and/or => 1 soft tissue lesion
Patient must have been previously treated with a next generation hormonal agent (NHA), ie, abiraterone, enzalutamide, apalutamide, or darolutamide, for prostate cancer for at least 3 months and shown evidence of disease progression while receiving the NHA
Serum testosterone level <= 50 ng/dL

Exclusion Criteria:
Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment
Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment)
Radiotherapy with a wide field of radiation (affecting => 30% of the bone marrow) within 4 weeks before the start of study treatment
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Location Contacts
Hershey, PA ,