Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
About This Trial
- This clinical trial is comparing two different schedules of radiation therapy delivered directly to the prostate.
- It is designed for people newly diagnosed with prostate cancer that has spread only to a small number of bones or lymph nodes.
- The goal is to find out which treatment schedule is most effective at controlling the disease while keeping side effects manageable.
- Before joining, patients should know that treatment must begin within nine months of diagnosis, and those with severe urinary problems or cancer that has spread to internal organs cannot participate.
More Information
- de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate.
- Two different fractionation schedules will be tested.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This clinical trial is comparing two different schedules of radiation therapy delivered directly to the prostate.
Study Details
- Start Date: October 31, 2022
- Lead Sponsor: Umeå University
Full Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent
- Histological confirmed prostate cancer
- Indication for early palliative radiation therapy of low burden metastatic prostate cancer. Low burden as defined by modified CHAARTED trial criteria to maximum 4 skeletal mets at any site and/or any number of lymph nodes
- baseline E-PROM
Exclusion Criteria
- High burden metastatic prostate cancer including all with visceral mets.
- Unable to comply with study procedures.
- Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy
- Radiation treatment start later than nine months after the prostate cancer diagnosis.
- Severe micturition problems, IPSS > 20 ( International Prostate Symptom Score)
Treatments
- Radiation: Moderate hypo-fractionation
- Radiation: Ultra-hypo-fractionation