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

Prostate Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382094
• Other study ID #: RCT-PC-QLS 2004
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2015
• Last updated: March 5, 2015
• Start date: June 2005
• Est. completion date: July 2012

Study information

• Verified date: March 2015
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board, Stockholm,
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		4 years	Yes
Secondary	PSA relapse		1year	Yes
Secondary	Time to symptom giving metastasis		1 year	Yes
Secondary	Overall survival		1 year	Yes