A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer

Not Applicable

Completed

• Conditions: ocalised prostate cancer; Cancer; Prostate

• Registration Number: ISRCTN97182923
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

2012 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/22169268 prospective analysis study 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22169269 preliminary safety results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26522334 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27339115 results 2018 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/29928699 sub-study protocol 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31767473 sub-study results (added 27/11/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37433374/ sub-study results (added 04/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-12
• Study Completion: 2011-06-17
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3216

Inclusion Criteria

1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
2. Clinical stage T1b ? T3a, N0, M0 (1997 TNM system)
3. Prostate Specific Antigen (PSA) less than 40 ng/ml
4. Estimated risk of lymph node metastases less than 30%
5. World Health Organisation (WHO) performance status zero or one
6. Normal blood count (Hb more than 11 g/dl, white blood cell count [WBC] more than 4000/mm^3, platelets more than 100,000/mm^3)
7. Written informed consent

Exclusion Criteria

1. Prior pelvic radiotherapy or radical prostatectomy
2. Previous androgen deprivation
3. Life expectancy less than ten years (less than five years for poorly differentiated cancers)
4. Previous active malignancy within the last five years other than basal cell carcinoma
5. Co-morbid conditions likely to impact on the advisability of radical radiotherapy (e.g. previously inflammatory bowel disease, previous colorectal surgery, significant bladder instability or urinary incontinence)
6. Full anticoagulation with e.g. Warfarin or Heparin
7. Hip prosthesis or fixation which would interfere with standard radiation beam configuration

Study & Design

• Study Type: Interventional
• Study Design: Not specified