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 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Bicalutamide

• Registration Number: NCT02382094
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Primary objective: To study the difference in quality of life in relation to anti-androgen versus total androgen blockage.

Exploratory parameters: ▪ Time to PSA relapse

* Time to symptom giving metastasis

* Overall survival

Patients with localized /locally advanced prostate cancer were subject to treatment with curative intention. They could be divided into three groups according to the risk of metastasis. Mainly intermediate risk group of patients were included in this study. Patients with low risk could be included if they were subject to neo-adjuvant hormonal therapy. Different risk groups were defined as below:

Low risk group: PSA ≤10 ng/ml Gleason score ≤ 6 Tumour stage ≤ T2b Intermediate risk group: Presence of 1-2 factors of high risk. High risk group: PSA \>10 ng/ml Gleason score ≥7 Tumour stage T2c - T3b

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2009-04
• Study Completion: 2012-07
• Status Verified: 2015-03
• Study First Submitted: 2015-03-05
• Study First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Study First Posted: 2015-03-06
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm AA(anti-androgen)	Bicalutamide	Bicalutamide 150 mg per os daily + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.
Arm TAB (Total androgen blockade)	Bicalutamide	Bicalutamide 50 mg orally daily + Goserelin 3.6 mg subcutaneously every 28±2 days + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.

Primary Outcome Measures

Name	Time	Method
Quality of Life	4 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year
PSA relapse	1year
Time to symptom giving metastasis	1 year