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
1 other identifier
interventional
110
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Jun 2005
Typical duration for phase_3 prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedMarch 6, 2015
March 1, 2015
3.8 years
March 5, 2015
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
4 years
Secondary Outcomes (3)
PSA relapse
1year
Time to symptom giving metastasis
1 year
Overall survival
1 year
Study Arms (2)
Arm AA(anti-androgen)
EXPERIMENTALBicalutamide 150 mg per os daily + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
Arm TAB (Total androgen blockade)
OTHERBicalutamide 50 mg orally daily + Goserelin 3.6 mg subcutaneously every 28±2 days + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
Interventions
Eligibility Criteria
You may not qualify if:
- Severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine \> 225 mmol/l.
- Concomitant diseases that would influence the planned treatment (e.g. Inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months.
- 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.
- Inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons
- Participation in other clinical studies at the same time if it considers may hamper the assessment of QoL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Majumder 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: 27459586DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 5, 2015
First Posted
March 6, 2015
Study Start
June 1, 2005
Primary Completion
April 1, 2009
Study Completion
July 1, 2012
Last Updated
March 6, 2015
Record last verified: 2015-03