NCT00148928

Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

A Multicenter, Open-label Phase I/II Trial to Evaluate the Safety and Activity of CPC-P501 Protein Formulated With the Adjuvant AS15 as First-line Treatment in Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients' long-term safety and PSA status will be followed over a period of approximately 11 months.

Detailed description

This Phase I/II study will be conducted according to a multicenter, open-label, single-group design at approximately ten centers in Europe. At least 21 HSPC patients with rising PSA after primary tumor treatment will be enrolled in this study. All patients will be treated as out-patients and will receive the same treatment. The maximum dose will be 16 vaccinations. Follow-up: The patients' long-term safety and PSA status will be followed over a period of 48 weeks. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Neoplasms, Prostate

Interventions

Type	Name	Description
BIOLOGICAL	P501-AS15 vaccine

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-11-07
• Completion: 2006-11-07
• First posted: 2005-09-08
• Last updated: 2017-06-02

Locations

8 sites across 2 countries: Belgium, France