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 naive, immunocompetent subjects with T1-3, N0-1/x, M0 prostate cancer, eligible for hormone therapy.

Completed

• Conditions: prostate cancer; 10038594; 10036958

• Registration Number: NL-OMON35662
• Lead Sponsor: Pepscan Therapeutics B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1 pathological confirmed prostatic adenocarcinoma, clinical
stage (c) cT1-3, cN0-1/x, cM0;
2 baseline testosterone levels of > 4 nmol/l;
3 baseline PSA level of > 10 µg/l;
4 eligible for hormone therapy;
5 willingness to comply with the protocol conditions and procedures;
6 willing and able to give informed consent.

Exclusion Criteria

1 clinical evidence of distant metastases;
2 previous (within 3 years before enrolment into the present study)hormonal therapy administered specifically for prostatic carcinoma;
3 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;
4 primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications;
5 concomitant administration -or administration during the 12 weeks preceding study inclusion- of immune enhancing medication or testosterone supplements;
6 presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion;
7 simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrolment into the present study;
8 BMI > 30 kg/m2;
9 a previous serious reaction to a vaccine such as angioedema or anaphylaxis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified