Testing different radiation schedules for metastatic prostate cancer
Official title: A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
Run by Umeå University · NCT04612907 · Data updated 2026-11-12
This study is testing whether a more intense radiation schedule works better and causes fewer side effects for people with newly diagnosed metastatic prostate cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 420 (estimated) |
| Sponsor | Umeå University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Umeå) |
| Status | Recruiting |
| Started | October 31, 2022 |
| Main results expected | June 30, 2026 |
| Study ends | September 30, 2032 |
| Registry record updated | February 28, 2024 |
| Trial ID | NCT04612907 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men with histologically confirmed prostate cancer and low burden metastatic disease, as defined by specific criteria.
✕Probably not a fit
Patients with high burden metastatic prostate cancer or those with severe urinary problems may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of two different radiation fractionation schedules for patients with de Novo metastatic prostate cancer that has limited spread. The standard schedule involves delivering 3 Gy of radiation over 19-20 sessions, while the trial will also evaluate a more intensive schedule of 6.1 Gy over 6 sessions. The goal is to compare the patient-reported side effects between these two approaches to determine which is more beneficial. Participants will be closely monitored for their responses to treatment and any adverse effects experienced.
Why it matters
Potential benefit: If successful, this study could lead to improved radiation treatment options that minimize side effects for patients with metastatic prostate cancer.
How similar studies have gone: Previous studies have shown promising results with hypo-fractionated radiotherapy approaches, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed Informed Consent 2. Histological confirmed prostate cancer 3. 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 4. baseline E-PROM Exclusion Criteria: 1. High burden metastatic prostate cancer including all with visceral mets. 2. Unable to comply with study procedures. 3. Other diseases or medication that will put the patient at risk for more toxicity from radiotherapy 4. Radiation treatment start later than nine months after the prostate cancer diagnosis. 5. Severe micturition problems, IPSS \> 20 ( International Prostate Symptom Score)
Where it's running
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Cancercenter University hospital of Umeå
Umeå, Sweden Recruiting
Study contacts
- Principal investigator: Camilla of T Karlsson — Cancercentrum Umeå University
- Study coordinator: Camilla Thellenberg Karlsson, MD, PhD
- Email: camilla.thellenberg@umu.se
- Phone: +46 90 785 3296
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.