Clinical trial · Interventional
Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
NCT00551044CI-TRIAL-00000930completedN/AClinicalTrials.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 aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for 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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Bicalutamide
- description
- Osteoporotic patients (T score ≤ -2.5) on bicalutamide
- interventionNames
- Drug: Bicalutamide
Primary outcomes (1)
- measure
- Quality of life (using Rand 36-Item Health Survey SF-36)
- timeFrame
- 3 monthly for 1 year
Secondary outcomes (4)
- measure
- Renal & liver function tests, PSA, testosterone, estradiol
- timeFrame
- 3 monthly for 1 year
- measure
- Body Mass Index, arm anthropometry (mid-upper arm circumference and triceps skin fold thickness), dynamometry (quadriceps muscle strength)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Osteoporotic patients (T score ≤ -2.5) with advanced prostate cancer requiring hormone manipulation, due to biochemical relapse following either radical prostatectomy, radiotherapy, brachytherapy, or biochemical progression after initially being observed with prostate cancer. Exclusion Criteria: * Severe hepatic insufficiency, with bilirubin above reference range * Previous systemic therapy for prostate cancer * Radiotherapy within 6 months * Previous other invasive malignancies * Any severe concomitant disease.
References
Publications (1)
- DERIVEDWadhwa VK, Weston R, Parr NJ. Bicalutamide monotherapy preserves bone mineral density, muscle strength and has significant health-related quality of life benefits for osteoporotic men with prostate cancer. BJU Int. 2011 Jun;107(12):1923-9. doi: 10.1111/j.1464-410X.2010.09726.x. Epub 2010 Oct 15. PMID 20950306