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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Pepscan Therapeutics.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895466
First Posted: May 8, 2009
Last Update Posted: May 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TFS Trial Form Support
Information provided by:
Pepscan Therapeutics
  Purpose
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 Intervention Phase
Prostate Cancer Biological: PEP-223/CoVaccine HT Phase 1 Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Pepscan Therapeutics:

Primary Outcome Measures:
  • Testosterone suppression [ Time Frame: after 12 weeks treatment as compared to baseline ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: October 2008
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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

Responsible Party: Chief Medical Officer, Pepscan Therapeutics
ClinicalTrials.gov Identifier: NCT00895466     History of Changes
Other Study ID Numbers: PEP223-NL-0701
First Submitted: May 6, 2009
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