Phase 1 Study to Find the Right Oral Dose of BP-C2 for Men with Prostate Cancer Receiving Hormone Therapy

What this Trial Is About

Researchers are evaluating the recommended oral dose of BP-C2 alongside hormone treatment in patients with prostate cancer. This Phase 1, open-label, multi-center study uses a Response Surface Pathway design to find the optimal dose for patients aged 18 to 80 years undergoing hormonal therapy. The trial aims to assess tolerability and toxicity using standardized criteria and quality of life measures. Treatment involves daily oral doses of BP-C2, starting at 1.0 mgkg body weight for four weeks, with dose adjustments every four weeks based on individual tolerability. Patients receive three successive four-week treatment levels where doses may be increased or decreased depending on adverse event severity. The trial includes close monitoring and dose changes guided by toxicity scores to optimize safety and dose recommendations. Participants undergo a seven-day screening with clinical exams and blood tests before starting treatment. Throughout the study and follow-up, researchers will measure adverse events using the CTCAE scale, quality of life with EQ-5D-5L questionnaires, and prostate-specific antigen levels. Safety, tolerability, and quality of life are assessed at regular intervals during treatment and at the four-week post-treatment follow-up, with total participation lasting approximately 15 weeks.

Recommended Dose Estimation of BP-C2