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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Androgen Antagonists; Androgens; Bicalutamide

Criteria

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.

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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.

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