Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Prof MK Parmar
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00002633
Protocol/serial number
G9805643 (PR07)
Study information
Scientific title
A randomised clinical trial of hormones plus radiotherapy vs hormone therapy alone in non-metastatic prostate cancer
Acronym
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.
More details can be found at: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=58
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/06/1999
Overall trial end date
31/08/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
1,200
Participant 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.
Recruitment start date
01/06/1999
Recruitment end date
31/08/2005
Locations
Countries of recruitment
United Kingdom, United States of America
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) Clinical Trials Unit - Cancer Division (UK)
Sponsor details
222 Euston Road
London
NW1 2DA
United Kingdom
-
abc@email.com
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
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Appraisal
Mason M, Warde P, Sydes M, Cowan R, James N, Kirkbride P, Langley R, Latham J, Moynihan C, Anderson J, Millet J, Nutall J, Moffat L, Parulekar W, Parmar M, , , Defining the need for local therapy in locally advanced prostate cancer: an appraisal of the MRC PR07 study., Clin Oncol (R Coll Radiol), 2005, 17, 4, 217-218.
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Results
Warde P, Mason M, Ding K, Kirkbride P, Brundage M, Cowan R, Gospodarowicz M, Sanders K, Kostashuk E, Swanson G, Barber J, Hiltz A, Parmar MK, Sathya J, Anderson J, Hayter C, Hetherington J, Sydes MR, Parulekar W, , Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer: a randomised, phase 3 trial., Lancet, 2011, 378, 9809, 2104-2111, doi: 10.1016/S0140-6736(11)61095-7.
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Protocol
Mason MD, Brewster S, Moffat LE, Kirkbride P, Cowan RA, Malone P, Sydes M, Parmar MK, Randomized trials in early prostate cancer. II: hormone therapy and radiotherapy for locally advanced disease: a question is still unanswered. MRC PR07 Trial Management Group., Clin Oncol (R Coll Radiol), 2000, 12, 4, 215-216.
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Results
Brundage M, Sydes MR, Parulekar WR, Warde P, Cowan R, Bezjak A, Kirkbride P, Parliament M, Moynihan C, Bahary JP, Parmar MK, Sanders K, Chen BE, Mason MD, Impact of Radiotherapy When Added to Androgen-Deprivation Therapy for Locally Advanced Prostate Cancer: Long-Term Quality-of-Life Outcomes From the NCIC CTG PR3/MRC PR07 Randomized Trial, J Clin Oncol, 2015, 33, 19, 2151-2157, doi: 10.1200/JCO.2014.57.8724.