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:

Collaborator:

TFS Trial Form Support

Information provided by:

Pepscan Therapeutics

ClinicalTrials.gov Identifier:

NCT00895466

First received: May 6, 2009

Last updated: May 7, 2009

Last verified: May 2009

History of Changes

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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	May 6, 2009
Last Updated:	May 7, 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

ClinicalTrials.gov processed this record on June 23, 2017

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