Conditions: Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms
Keywords: prostate cancer castration resistant prostate cancer bone pain CRPC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 119
Healthy volunteers: no

Brief summary:
Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases.

This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Detailed description:

Arms:
arm 1: Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

There will be a maximum of 10 infusions for mitoxantrone placebo. arm 2: Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

There will be a maximum of 10 infusions for mitoxantrone.

Interventions: intervention 1: cabozantinib intervention 2: mitoxantrone intervention 3: prednisone
Intervention descriptions: intervention 1: Tablets taken orally once daily. intervention 2: Given by IV once every 3 weeks. intervention 3: Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Protocol document: