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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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Bicalutamide

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring curative intention, radiation Therapy, health related quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Histopathologically verified prostatic adenocarcinoma.
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.
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.
No signs of distant metastasis.
Informed consent.
-

Exclusion Criteria:

Failure to fulfill inclusion criteria.
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.
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Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm AA(anti-androgen)

Arm TAB (Total androgen blockade)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of Life

Secondary Outcome Measures

PSA relapse

Time to symptom giving metastasis

Overall survival

Full Information

NCT ID

NCT02382094

First Posted

March 5, 2015

Last Updated

March 5, 2015

Sponsor

Karolinska University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02382094

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

June 2005 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

curative intention, radiation Therapy, health related quality of life

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm AA(anti-androgen)

Arm Type

Experimental

Arm Description

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

Arm Title

Arm TAB (Total androgen blockade)

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bicalutamide

Other Intervention Name(s)

Casodex

Primary Outcome Measure Information:

Title

Quality of Life

Time Frame

4 years

Secondary Outcome Measure Information:

Title

PSA relapse

Time Frame

1year

Title

Time to symptom giving metastasis

Time Frame

1 year

Title

Overall survival

Time Frame

1 year

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Histopathologically verified prostatic adenocarcinoma. 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. 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. No signs of distant metastasis. Informed consent. - Exclusion Criteria: Failure to fulfill inclusion criteria. 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. -

12. IPD Sharing Statement

Citations:

PubMed Identifier

27459586

Citation

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.

Results Reference

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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

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