Clinical trial · Interventional
Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.
Phase 2 Trial of Maximum Androgen Blockade (MAB) Dose Escalation From 50 mg to 150 mg Bicalutamide (Casodex) for Biochemical Failure in Prostate Cancer Patients
- 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)
Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal. Treatment will be continued after one year if patient demonstrates continued clinical benefit.
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 |
|---|---|---|---|
| Escalating dose of Casodex from 50mg daily to 150 mg daily | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Doubling of PSA
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of written informed consent. 2. Men, over 18 years of age, with histologically-confirmed prostate cancer 3. Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1 4. Serum testosterone level \< 50 ng/ml 5. Current treatment with bicalutamide 50 mg daily.\*\* 6. Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA \> 2.0 ng/ml. 7. Highest PSA level no greater than or equal to 30 ng/ml. 8. Life expectancy of greater than 1 year - Exclusion Criteria: 1. Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.\* 2. PSA level greater than 30 ng/ml. 3. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial. 4. Subjects who have received prior chemotherapy. 5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder. 6. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L. 7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). 8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR. 9. Serum creatinine greater than 1.5 times -
References
Publications (0)
Data not yet available