Clinical trial · Interventional
Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEP-223/CoVaccine HT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Testosterone suppression
- timeFrame
- after 12 weeks treatment as compared to baseline
Secondary outcomes (5)
- measure
- The time course of testosterone suppression
- timeFrame
- after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
- measure
- Effects on LH and FSH levels
- timeFrame
- after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
- measure
- Effects on PSA levels
- timeFrame
- after 2, 4, 6, 8, 10 and 12 weeks treatment as compared to baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available