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

Phase 1

Completed

• Conditions: Neoplasms, Prostate

• Registration Number: NCT00148928
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Study Timeline

• Study Start: 2005-03-01
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2006-11-07
• Study Completion: 2006-11-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vaccine-related or possibly vaccine-related Grade 3 or 4 adverse event: a. Any Grade 4 toxicity: fatigue (including lethargy, asthenia, malaise) must have a duration of at least 24 hours. b. Any Grade 3 toxicity with a duration of at least 24 hours	During the study
Clinical PSA response

Secondary Outcome Measures

Name	Time	Method
a. For patients who present a PSA response: The duration of PSA response, The duration of PSA control, The duration of log PSA response.	During the study
b. Humoral immune response induced by P501-AS15 vaccine: Anti-CPC seropositivity. Anti-P501 seropositivity.	At all points during treatment as specified in the study schedule
c. Cellular immune response induced by P501-AS15 vaccine. Frequency of in vitro cellular immune response to CPC P501.	At all points during treatment as specified in the study schedule
d. Any toxicity in terms of solicited symptoms, unsolicited symptoms and serious adverse events.	During the study
e. All adverse events, whether or not associated with toxicity.	During the study
f. General laboratory safety variables.	At all points during treatment as specified in the study schedule

Trial Locations

Locations (1)

GSK Investigational Site; 🇫🇷 Villejuif Cedex, France