Phase III study of HYPOfractionated RadioTherapy of intermediate risk localised Prostate Cancer

Phase 3

Completed

• Conditions: Intermediate risk localised prostate cancer; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN45905321
• Lead Sponsor: County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31227373 (added 24/06/2019) 2021 quality of life results in https://pubmed.ncbi.nlm.nih.gov/33444529/ (added 15/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-10
• Study Completion: 2015-06-30
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 1200

Inclusion Criteria

1. Men less than 75 years of age and, as judged by the doctor, a life expectancy of 10 years (except for cancer) at time of randomisation with performance status World Health Organization (WHO) grades 0 - 2
2. Patients with a histologically verified prostatic cancer
3. Patients with intermediate risk prostatic cancer of clinical category T1c - T3a with one or two of the following risk factors:
3.1. T3a or Gleason greater than 7
3.2. PSA greater than 10 according to the TNM classification system UICC 2002
4. PSA less than 20 µg/L
5. The patients should have no evidence of metastases according to the definition above
6. Patients should be lymph node negative according to the definition above, i.e. staging
7. Patients should be suitable for radiotherapy
8. Patients must have signed informed consent

Exclusion Criteria

1. Patients who earlier have undergone any other treatment for prostatic cancer
2. Patients unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis)
3. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
4. Previous hormone therapy (castration or anti-androgens)
5. Any condition that prevent markers implantation, i.e. anal fissure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from failure (PSA or any clinical), measured five years after the end of treatment.

Secondary Outcome Measures

Name	Time	Method
<br> 1. PSA response rate<br> 2. Time to symptoms related to local progression<br> 3. Time to symptoms related to distant progression<br> 4. Cancer specific survival<br> 5. Overall survival<br> 6. Quality of Life (QoL) and side effects with special focus on sexual function, urinary and gastrointestinal morbidity<br><br> Measured five years after the end of treatment.<br>