{"registry": "ISRCTN", "registryId": "ISRCTN97182923", "source": "https://www.isrctn.com/ISRCTN97182923", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN97182923/format/default", "fetchedAt": "2026-10-07T17:00:23.845523Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer", "scientificTitle": "A randomised phase III multi-centre trial of Conventional or Hypofractionated High dose Intensity modulated radiotherapy for Prostate cancer", "acronym": "CHHIP", "hypothesis": "To test the hypothesis that hypofractionated radiotherapy schedules for localised prostate cancer will improve the therapeutic ratio by either:\n1. Improving tumour control\n2. Reducing normal tissue side effects", "primaryOutcome": "Acute and late radiation induced side-effects", "secondaryOutcome": "1. Freedom from prostate cancer recurrence\n2. Development of metastases\n3. Recommencement of hormonal treatment for disease occurrence\n4. Cause specific and overall survival\n5. Aspects of quality of life and health economics\n6. Models of normal tissue and tumour control", "intervention": "\n\t1. Control group: neoadjuvant hormone therapy and external beam radiotherapy (IMRT) 74 Gy in 37 fractions over 7.5 weeks.\n2. Hypofractionation group one: neoadjuvant hormone therapy and external beam radiotherapy (IMRT) 57 Gy in 19 fractions over four weeks.\n3. Hypofractionation group two: neoadjuvant hormone therapy and external beam radiotherapy (IMRT) 60 Gy in 20 fractions over four weeks.\n\tMixed\n\t\n\t\n      ", "condition": "\n\tLocalised prostate cancer\n\tCancer\n\tProstate\n      ", "studyDesign": "Randomised controlled trial", "overallEndDate": "2011-06-17T00:00:00.000Z", "clinicalTrialsGovNumber": "NCT00392535", "lastUpdated": "2024-06-04T16:49:17.525162Z", "eligibility": {"inclusion": "1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate\n2. Clinical stage T1b – T3a, N0, M0 (1997 TNM system)\n3. Prostate Specific Antigen (PSA) less than 40 ng/ml\n4. Estimated risk of lymph node metastases less than 30%\n5. World Health Organisation (WHO) performance status zero or one\n6. 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)\n7. Written informed consent", "exclusion": "1. Prior pelvic radiotherapy or radical prostatectomy\n2. Previous androgen deprivation\n3. Life expectancy less than ten years (less than five years for poorly differentiated cancers)\n4. Previous active malignancy within the last five years other than basal cell carcinoma\n5. 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)\n6. Full anticoagulation with e.g. Warfarin or Heparin\n7. Hip prosthesis or fixation which would interfere with standard radiation beam configuration", "ageRange": "Adult", "gender": "All", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "2002-10-18T00:00:00.000Z", "recruitmentEnd": "2011-06-17T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "3170", "totalFinalEnrolment": "3216"}, "countries": ["United Kingdom", "England", "Ireland", "New Zealand", "Switzerland"], "locations": [{"name": "Royal Marsden NHS Trust", "city": "Sutton", "state": "", "country": "United Kingdom", "zip": "SM2 5PT"}], "sponsors": [{"organisation": "Institute of Cancer Research (UK)", "sponsorType": "Research organisation", "rorId": "https://ror.org/043jzw605"}], "funders": [{"name": "CTAAC"}]}, "studySha256": "bf6feabab0cafcb1927e1e75af3183aac9f35aa9a288f7b6b5711a2169f823eb"}