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

May 7, 2009 updated by: Pepscan Therapeutics

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Testosterone suppression
Time Frame: after 12 weeks treatment as compared to baseline
after 12 weeks treatment as compared to baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
The time course of testosterone suppression
Time Frame: after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
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
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
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
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
as applicable

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pepscan Therapeutics

Collaborators

TFS Trial Form Support

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (ESTIMATE)

May 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2009

Last Update Submitted That Met QC Criteria

May 7, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP223-NL-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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