Clinical trial · Interventional
Bicalutamide Compared With Observation Followed by Bicalutamide Plus Either Goserelin or Orchiectomy in Treating Patients With Prostate Cancer
Randomized Phase III Step-Up Study On Initial Antiandrogen Monotherapy In Comparison With Watchful Waiting In Asymptomatic T1-3 Any G (Any Gleason) NO or Nx M0 Prostate Cancer Patients Without Local Treatment With Curative Intent
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Testosterone can stimulate the growth of cancer cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known which hormone therapy regimen is most effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of bicalutamide with that of observation followed by bicalutamide plus either goserelin or orchiectomy for patients who have 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 |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| goserelin acetate | Drug | Goserelin | ALIAS |
| orchiectomy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * T1-3, any G (any Gleason), N0 or NX * High risk defined as G3 or Gleason more than 6 or PSA more than 20 ng/mL and unfit or unwilling to undergo local curative therapy OR * Low risk defined as G1-2 or Gleason less than 7 and PSA no more than 20 ng/mL and no prior local curative therapy * Asymptomatic (pain score of 0) * PSA no more than 100 ng/mL (no more than 25 times normal) * No metastatic disease by chest x-ray, bone scan (if PSA more than 10 ng/mL or 2.5 times normal), and pelvic CT (if chance of lymph node metastases is at least 5% by Partin tables) * No bone disease that would interfere with diagnosis of metastatic disease PATIENT CHARACTERISTICS: Age: * 80 and under Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 5 years except adequately treated basal cell skin cancer * No psychological, personal, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available