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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
PEP-223/CoVaccine HT
Sponsored by
Pepscan Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Prostate Cancer focused on measuring prostatic diseases, neoplasms, prostatic neoplasms, hormones, androgen antagonists, vaccines, peptide vaccines, adjuvants, immunological

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UMC GroningenRecruiting
  • UMC NijmegenRecruiting

Outcomes

Primary Outcome Measures

Testosterone suppression

Secondary Outcome Measures

The time course of testosterone suppression
Effects on LH and FSH levels
Effects on PSA levels
Antibody response to PEP223/CoVaccine HT
Safety (adverse events, laboratory values, injection site reactions)

Full Information

First Posted
May 6, 2009
Last Updated
May 7, 2009
Sponsor
Pepscan Therapeutics
Collaborators
TFS Trial Form Support
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1. Study Identification

Unique Protocol Identification Number
NCT00895466
Brief Title
Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2009 (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pepscan Therapeutics
Collaborators
TFS Trial Form Support

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostatic diseases, neoplasms, prostatic neoplasms, hormones, androgen antagonists, vaccines, peptide vaccines, adjuvants, immunological

7. Study Design

Study Phase
Phase 1, Phase 2
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
PEP-223/CoVaccine HT
Primary Outcome Measure Information:
Title
Testosterone suppression
Time Frame
after 12 weeks treatment as compared to baseline
Secondary Outcome Measure Information:
Title
The time course of testosterone suppression
Time Frame
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Title
Effects on LH and FSH levels
Time Frame
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Title
Effects on PSA levels
Time Frame
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Title
Antibody response to PEP223/CoVaccine HT
Time Frame
after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
Title
Safety (adverse events, laboratory values, injection site reactions)
Time Frame
as applicable

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Drug Development
Email
info@pepscan.com
Facility Information:
Facility Name
UMC Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Nijmegen
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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