A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer
ISRCTN | ISRCTN24991896 |
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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
Contact information
Prof MK Parmar
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
abc@email.com |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer |
Study objectives | To 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) studied | Prostate cancer |
Intervention | All patients will receive hormonal manipulation. Patients are randomised to receive: 1. Additional radiotherapy (65-69Gy/35-37f) 2. No additional radiotherapy |
Intervention type | Mixed |
Primary outcome measure | Overall survival |
Secondary outcome measures | 1. 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 date | 01/06/1999 |
Completion date | 31/08/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Male |
Target number of participants | 1,200 |
Key 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 |
Key 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. |
Date of first enrolment | 01/06/1999 |
Date of final enrolment | 31/08/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
- United States of America
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)
Research council
Research council
222 Euston Road
London
NW1 2DA
United Kingdom
abc@email.com | |
Website | http://www.ctu.mrc.ac.uk/ |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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)