Clinical trial · Interventional
Clinical Trial to Study Quality of Life in Prostate Cancer Patients by Randomizing Anti-androgen Versus Total Androgen Blockage Prior to Curative Intended Radiation Therapy
NCT02382094CI-TRIAL-00017022completedPhase 3ClinicalTrials.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)
Phase III clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.
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 |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm AA(anti-androgen)
- description
- Bicalutamide 150 mg per os daily + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
- interventionNames
- Drug: Bicalutamide
- type
- OTHER
- label
- Arm TAB (Total androgen blockade)
- description
- Bicalutamide 50 mg orally daily + Goserelin 3.6 mg subcutaneously every 28±2 days + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
- interventionNames
- Drug: Bicalutamide
Primary outcomes (1)
- measure
- Quality of Life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
1. Histopathologically verified prostatic adenocarcinoma. 2. All consecutive patients referred for radiation therapy with combination method i.e. both external beam RT and HDR brachytherapy or other fractionation with curative intention. 3. Patients with intermediate risk group of prostate cancer will mainly be included in this study where radiotherapy with intention to cure is indicated and possible to perform. The intermediate risk group is defined as having 1-2 high risk factors for metastasis. Patients with low risk can only be possible to include if there is an indication of neo-adjuvant hormonal therapy. 4. No signs of distant metastasis. 5. Informed consent. \- Exclusion Criteria: 1. Failure to fulfill inclusion criteria. 2. Severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine \> 225 mmol/l. 3. Concomitant diseases that would influence the planned treatment (e.g. Inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months. 4. Previous diagnosis of other malignant diseases excluding patients who are free from relapse after at least 5 years of diagnosis. Patients with basal cell carcinoma are includable. 5. Inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons 6. Participation in other clinical studies at the same time if it considers may hamper the assessment of QoL. \-
References
Publications (1)
- DERIVEDMajumder K, Nilsson S, Johansson H, Ullen A, Lennernas B, Bergenmar M, Brandberg Y. Higher sexual interest with androgen receptor inhibitor monotherapy than with castration plus an androgen receptor inhibitor in prostate cancer patients treated with curative radiotherapy, but otherwise small health-related quality of life differences: A randomised prospective 18-month follow-up study. Eur J Cancer. 2016 Sep;65:43-51. doi: 10.1016/j.ejca.2016.06.011. Epub 2016 Jul 25. PMID 27459586