Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Biological: PEP-223/CoVaccine HT	Phase 1; Phase 2

Detailed Description:

Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.

Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.

In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	12 participants
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.
Study Start Date :	October 2008
Primary Completion Date :	December 2009

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Testosterone suppression [ Time Frame: after 12 weeks treatment as compared to baseline ]

Secondary Outcome Measures :

1. The time course of testosterone suppression [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ]
2. Effects on LH and FSH levels [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ]
3. Effects on PSA levels [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ]
4. Antibody response to PEP223/CoVaccine HT [ Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline ]
5. Safety (adverse events, laboratory values, injection site reactions) [ Time Frame: as applicable ]

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Drug Development		info@pepscan.com

Locations

Netherlands
UMC Groningen	Recruiting
Groningen, Netherlands, 9713 GZ
UMC Nijmegen	Recruiting
Nijmegen, Netherlands

Sponsors and Collaborators

Pepscan Therapeutics

TFS Trial Form Support

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Chief Medical Officer, Pepscan Therapeutics
ClinicalTrials.gov Identifier:	NCT00895466 History of Changes
Other Study ID Numbers:	PEP223-NL-0701
First Posted:	May 8, 2009
Last Update Posted:	May 8, 2009
Last Verified:	May 2009

Keywords provided by Pepscan Therapeutics:

prostatic diseases; neoplasms; prostatic neoplasms; hormones	androgen antagonists; vaccines; peptide vaccines; adjuvants, immunological

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male	Prostatic Diseases; Vaccines; Hormones; Immunologic Factors; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists