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.

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. - PEP223-NL-701

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35662

Enrollment

Registered

2008-06-04

Start date

2008-12-10

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Three adminstrations (2 weeks apart) of 7 µg conjugated modified GnRH peptide (PEP-223) in 2 ml of total vaccine (containing 0,5 ml adjuvant). This is to be administrated as as 2 x 1 ml IM injection

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary efficacy parameter: serum testosterone levels	—

Secondary

Measure	Time frame
Secondary efficacy parameters: - serum FSH levels, serum LH levels and serum anti-GnRH Ab levels. Safety parameters: - (spontaneous) reports of adverse events - laboratory data (endocrinology, hematology, biochemistry) and urinalysis - ECG - blood pressures, pulse rate, respiratory rate, body temperature - Physical examination - serum PSA levels	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)