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

NCT ID: NCT02382094

Last Updated: 2015-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2012-07-31

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm AA(anti-androgen)

Bicalutamide 150 mg per os daily + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.

Group Type: EXPERIMENTAL

Bicalutamide

Intervention Type: DRUG

Arm TAB (Total androgen blockade)

Bicalutamide 50 mg orally daily + Goserelin 3.6 mg subcutaneously every 28±2 days + if needed Tamoxifen 10 mg against breast tenderness/gynecomasti.

Group Type: OTHER

Bicalutamide

Intervention Type: DRUG

Interventions

Bicalutamide

Intervention Type: DRUG

Other Intervention Names

Casodex

Eligibility Criteria

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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• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

khairul Majumder

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 27459586 (View on PubMed)

Other Identifiers

RCT-PC-QLS 2004

Identifier Type: -

Identifier Source: org_study_id