Conditions: Prostatic Neoplasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.

Detailed description:
This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.

Arms:
arm 1: GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.

Interventions: intervention 1: Mitoxantrone intervention 2: GM-CSF
Intervention descriptions: intervention 1: Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic. intervention 2: GM-CSF is a biologic response modifier, classified as a colony stimulating factor.

Protocol document: