Prostate Cancer Clinical Trial
Official title:
A Phase I-II Open Label Clinical Trial, Evaluating the Efficacy and Safety of Administration of the Therapeutic Vaccine PEP-223/CoVaccine HT, to Hormone Treatment naïve, Immunocompetent Subjects With T1-3, N0-1/x, M0 Prostate Cancer, Eligible for Hormone Therapy.
The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0 - baseline testosterone levels of > 4 nmol/l - baseline PSA level of > 10 microg/l - eligible for hormone therapy - willingness to comply with the protocol conditions and procedures - willing and able to give informed consent Exclusion Criteria: - clinical evidence of distant metastases - previous hormonal therapy administered specifically for prostatic carcinoma - development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin - primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications - concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements - concomitant radiotherapy for prostate cancer - presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion - simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study - BMI > 30 kg/square meter - previous serious reaction to a vaccine such as angioedema or anaphylaxis |
N/A
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Groningen | Groningen | |
Netherlands | UMC Nijmegen | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Pepscan Therapeutics | TFS Trial Form Support |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Testosterone suppression | after 12 weeks treatment as compared to baseline | No | |
Secondary | The time course of testosterone suppression | after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline | No | |
Secondary | Effects on LH and FSH levels | after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline | No | |
Secondary | Effects on PSA levels | after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline | No | |
Secondary | Antibody response to PEP223/CoVaccine HT | after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline | No | |
Secondary | Safety (adverse events, laboratory values, injection site reactions) | as applicable | Yes |
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