Clinical trial · Interventional
Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer
Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
- 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)
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer. PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyproterone acetate | Drug | Cyproterone Acetate | ALIAS |
| gonadotrophin releasing hormone | Biological | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
- measure
- Time to treatment failure (subjective or objective progression)
- measure
- Quality of life
- measure
- Survival
Secondary outcomes (2)
- measure
- Side effects
- measure
- First and total therapy-free intervals in patients treated with intermittent cyproterone acetate
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 79 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * T3 -T4, M0-M1 (stage III or IV disease) * Prostate-specific antigen level ≥ 4 ng/mL and ≤ 100 ng/mL PATIENT CHARACTERISTICS: * Performance status 0-2 * Normal liver function * No other neoplasia (except skin, excluding melanoma) * No expected difficulties of follow-up related to psychiatric disorders, marked senility, or too large a distance between patient's home and investigator's center * No severe chronic disease PRIOR CONCURRENT THERAPY: * No prior hormonal therapy or chemotherapy * No prior surgery (radical prostatectomy), except transurethral resection, for M0 patients * No prior radiotherapy to the primary tumor for M0 patients
References
Publications (0)
Data not yet available