Clinical trial · Interventional
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy
Phase II Study of Bicalutamide and Dutasteride for Prostate Cytoreduction Prior to Permanent Implant I-125 Prostate Brachytherapy
NCT00866554CI-TRIAL-00066893completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 study is to determine if a combination of neoadjuvant dutasteride and bicalutamide has the same efficacy and less toxicity than standard treatment with an LHRH agonist and bicalutamide for prostate cytoreduction prior to permanent implant brachytherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| administration of a LHRH agonist and Bicalutamide | Drug | — | UNRESOLVED |
| administration of Bicalutamide, Dutasteride and Tamoxifen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LHRH agonist
- description
- Administration of a 3-month treatment with an LHRH agonist (chosen by the treating radiation oncologist) and Bicalutamide 50 mg daily for the first month of treatment with the LHRH agonist.
- interventionNames
- Drug: administration of a LHRH agonist and Bicalutamide
- type
- EXPERIMENTAL
- label
- Dutasteride, Bicalutamide, Tamoxifen
- description
- Administration of Dutasteride given at dose of 0.5 mg daily starting three months prior to day of implant procedure and continued for 3 months up until procedure. Bicalutamide: given at a dose of 50 mg daily for 3 the same 3 month period as dutasteride Tamoxifen: given at dose of 10 mg daily for 3 months that dutasteride and bicalutamide are administered.
- interventionNames
- Drug: administration of Bicalutamide, Dutasteride and Tamoxifen
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male sex * Diagnosis of prostate adenocarcinoma as confirmed by prostate biopsy * Prostate cancer with stage T1a, T1b T2a or T2b Nx Mx as determined by clinical examination * Gleason score of 6 or less or 7 (3+4)\* \* If Gleason score is 7(3+4) patient must have less than 30% of biopsied tissue positive * Serum PSA of ≤ 15ng/ml during the month before study entry * Prostate volume ≥ 45cc * Normal serum testosterone during the month before study entry * Availability for treatment and follow-up visits * Having signed required consent form before study entry Exclusion Criteria: * Abnormal Liver Function tests (\>2x normal AST or ALT and/or \>1.5x normal bilirubin) * Prostate volume less than 50 cc * History of hormonal treatment including any of the above: LHRH agonists, antiandrogens during the year before study entry * Use of a 5 alpha reductase inhibitor for more than one month during the year prior to study entry * History of pelvic irradiation * History of past chemotherapy * History of TURP * History of past treatment for prostate cancer * Known hypersensitivity to Dutasteride or Bicalutamide * Co-morbid disease possibly compromising treatment compliance * History of DVT or pulmonary embolism * Anticoagulation with coumarin * Inability to give consent
References
Publications (0)
Data not yet available
No reference posted for this study.