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

ISRCTN ISRCTN24991896
DOI https://doi.org/10.1186/ISRCTN24991896
ClinicalTrials.gov number NCT00002633
Secondary identifying numbers G9805643 (PR07)
Submission date
06/04/2000
Registration date
06/04/2000
Last edited
18/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-hormone-therapy-with-or-without-radiotherapy-in-advanced-prostate-cancer

Contact information

Prof MK Parmar
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer
Study objectivesTo evaluate any possible benefit from the addition of external beam radiation therapy to the treatment of patients with non-metastatic prostate cancer who have not had a radical prostatectomy and are receiving hormonal therapy.

More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=58
Ethics approval(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedProstate cancer
InterventionAll patients will receive hormonal manipulation.
Patients are randomised to receive:
1. Additional radiotherapy (65-69Gy/35-37f)
2. No additional radiotherapy
Intervention typeMixed
Primary outcome measureOverall survival
Secondary outcome measures1. Time to disease progression
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)
3. Quality of Life measured by the FACT-P questionnaire
Overall study start date01/06/1999
Completion date31/08/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants1,200
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment01/06/1999
Date of final enrolment31/08/2005

Locations

Countries of recruitment

  • England
  • United Kingdom
  • United States of America

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)
Research council

222 Euston Road
London
NW1 2DA
United Kingdom

Email abc@email.com
Website http://www.ctu.mrc.ac.uk/
ROR logo "ROR" https://ror.org/03x94j517

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Plain English results No Yes
Protocol article protocol 01/11/2000 Yes No
Other publications appraisal 01/06/2005 Yes No
Results article results 17/12/2011 Yes No
Results article results 01/07/2015 Yes No

Editorial Notes

18/10/2018: Cancer Research UK lay results summary link added to Results (plain English)