Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
Status:
Not yet recruiting
Trial end date:
2029-12-01
Target enrollment:
Participant gender:
Summary
The study is an open label, multi-centre, randomized phase III study. The patients will be
randomised in a 2:1 ratio to treatment consisting of
- Arm A: MD-SBRT in addition to standard treatment
- Arm B: Standard treatment
Study population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic
disease detected by PSMA-PET/DT. This includes patients with de novo oligometastatic HSPC and
recurrent HSPC after primary RT or prostatectomy.
Primary endpoint: Failure free survival (time to castration resistant prostate cancer, CRPC)
Secondary endpoints:
- Predictive value of investigated biomarkers in blood and imaging
- Acute and late toxicity after MD-SBRT
- PROM at 3 months, 1, 3 and 5 years
- Overall survival
- Differences in outcome between patients by strata
Stratification: To avoid imbalance between treatment arms the minimisation method will be
used to achieve balance between de novo oligo-metastatic and oligo-recurrent patients, as
well as treatment site.
Safety evaluation: Adverse events and side effects graded according to CTCAE v5.0 will be
collected every 6th month. Serious Adverse Events are to be reported within 24 hours
throughout the study duration.
Statistical methods: Survival endpoints will be calculated using the Kaplan-Meier method with
differences compared using the stratified log-rank test. Randomization time is set as
baseline time. Pre-planned subgroup analysis will occur based on pre-specified stratification
variables. A Cox multivariable regression model will be used to determine factors predictive
of survival. Safety analysis will be performed with Mann-Whitney U-test or Fishers exact
test.
Criteria for evaluation: Per protocol (patients that have started study treatment) and
Intention to treat (all included patients).
Planned sample size: 114 patients
Analysis plan:
The primary end point will be analysed after pre-specified number of events have occurred or
at 60 months of follow up. Safety analysis of acute toxicity will take place after median
follow up of 6 months. Safety analysis of late toxicity will be analysed after study closure.
Duration of the study:
Three to five years inclusion. 60 months of follow-up after randomization of the last
patient.
Phase:
Phase 3
Details
Lead Sponsor:
Umeå University
Collaborators:
Karolinska University Hospital Region Jönköping County Region Örebro County Region Skane Stockholm South General Hospital University Hospital, Umeå Vastra Gotaland Region