Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
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ClinicalTrials.gov Identifier: NCT00895466 |
Recruitment Status
: Unknown
Verified May 2009 by Pepscan Therapeutics.
Recruitment status was: Recruiting
First Posted
: May 8, 2009
Last Update Posted
: May 8, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Biological: PEP-223/CoVaccine HT | Phase 1 Phase 2 |
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 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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895466
Contact: Drug Development | info@pepscan.com |
Netherlands | |
UMC Groningen | Recruiting |
Groningen, Netherlands, 9713 GZ | |
UMC Nijmegen | Recruiting |
Nijmegen, Netherlands |
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 Key Record Dates |
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 |