A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer

Completed

• Conditions: Prostate cancer; Cancer

• Registration Number: ISRCTN24991896
• Lead Sponsor: Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)

Brief Summary

1. 2000 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/11005685 2. 2005 appraisal in: http://www.ncbi.nlm.nih.gov/pubmed/15997913 3. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22056152 4. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26014295

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-04-06
• Study Completion: 2005-08-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1200

Inclusion Criteria

1. Histological diagnosis of adenocarcinoma of the prostate within 6 months of randomisation
2. Either (a) clinical stage T3 or T4, NO or NX, MO or (b) clinical stage T2, NO or NX, MO with Prostate-Specific Antigen (PSA) greater than 40 or (c) clinical stage T2, NO or NX, MO with PSA greater than 20 and Gleason sum score greater than or equal to 8
3. The patient must have a bone scan (with X-rays of any areas of abnormal uptake) reported as being free of evidence of bony metastases within 16 weeks prior to randomisation (if not already on hormones) or 16 weeks prior to the start of hormones (if on hormones already)
4. No previous treatment for prostate cancer apart from transurethral resection. However, the patient may have received prior hormone therapy during the 12 weeks prior to randomisation, provided that (a) a negative bone scan was demonstrated, preferably within the 16 weeks prior to starting hormone therapy but certainly within 2 weeks after starting hormone therapy and (b) baseline PSA within 4 weeks prior to hormone therapy is available
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Patients must be less than 80 years old
7. Written informed consent

Exclusion Criteria

1. A history of previous or concurrent malignancy other than non-melanomatous skin cancer within 5 years of diagnosis of the prostatic cancer.
2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
3. Any contraindication to pelvic radiotherapy (e.g. inflammatory bowel disease).
4. Any serious non-malignant disease resulting in a life expectancy of less than 5 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
1. Time to disease progression<br>2. Symptomatic local control measured by the rates of surgical interventions necessary for symptomatic local disease (I.e. the combined incidences of TURPs, stent insertions, nephrostomies and colostomies)<br>3. Quality of Life measured by the FACT-P questionnaire