| Source of record | UK Trials |
| ISRCTN | ISRCTN24991896 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | G9805643 (PR07) |
| Public title | A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Prostate cancer |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration.
|
| Countries of trial | United States of America and United Kingdom |
| Participants - 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 |
| Participants - 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. |
| Patient information material |
|
| Anticipated start date | 01/06/1999 |
| Anticipated end date | 31/08/2005 |
| Status of trial | Completed |
| Target number of participants | 1200 |
| Interventions | All patients will receive hormonal manipulation.
Patients are randomised to receive:
1. Additional radiotherapy (65-69Gy/35-37f)
2. No additional radiotherapy. |
| Primary outcome measure(s) | Overall survival |
| Secondary outcome measure(s) | 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 |
| Trial website | http://www.ctu.mrc.ac.uk/studies/PR07.asp |
| Publications | Study protocol on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11005685 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK) |
| Sponsor details | 222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor website | http://www.ctu.mrc.ac.uk/ |
| Contact name | Prof MK Parmar |
| Contact details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN24991896 |
| Date last extracted from ISRCTN register | 17/04/2008 |
