Cancercenter University hospital of Umeå
Umeå, 90596, Sweden
Location status: Recruiting
Location contact
Camilla Thellenberg Karlsson, MD, PhD
CONTACT
Karin Söderkvist, MD, PhD
CONTACT
NCT Number: NCT04612907
de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.
Interested in participating?
Request Info18 year and older
Male
Interventional
Not applicable
Umeå, 90596, Sweden
Location status: Recruiting
Camilla Thellenberg Karlsson, MD, PhD
CONTACT
Karin Söderkvist, MD, PhD
CONTACT
Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks.
There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive four weeks of radiotherapy
Patients will receive two and a half weeks of radiotherapy
Time frame: 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS (Prostate Cancer Symptom Scale) bother score for urinary tract will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Time frame: 8 weeks
Acute toxicity score by PROM at eight weeks post radiotherapy. The mean PCSS bother score for bowel will be measured. The primary outcome measurement will be the difference between mean values in the respective treatment arms measured at 8 weeks after end of radiotherapy
Time frame: 12 months, 36 months
To evaluate the proportion of patients that are failure free at 12 and 36 months, failure free survival (FFS)
Contact information is provided by the study sponsor or research team.
Camilla Thellenberg Karlsson, MD, PhD
CONTACT
Karin Söderkvist, MD, PhD
CONTACT
Umeå University
Other
A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer
Acronym: Hypo-M1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05919264
Adamantinomatous Craniopharyngioma, Adenocarcinoma
Phoenix, Arizona, United States
View Trial DetailsNCT04585750
Adnexal Diseases, Advanced Malignant Neoplasm
Irvine, California, United States
View Trial DetailsNCT05183074
Adaptive Radiotherapy, Genital Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT05786742
Brachytherapy, Genital Diseases
Québec, Canada
View Trial Details