Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? Androgen Deprivation Therapy+Radiotherapy
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation, Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 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 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 * Castration resistant prostate cancer, CRPC * 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: 118 patients Analysis plan: The primary end point will be analysed after pre-specified number of events have occurred. All patients randomised to SBRT will be followed minimum 60 months for toxicity. 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. 72 months of follow-up after randomization of the last patient.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed prostate cancer (ICD-O-3 C61)

• WHO/ECOG performance status 0-1

• 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET/CT in de novo prostate cancer or PSA-relapse after definitive RT or prostatectomy

• Willing and able to provide informed consent-

Locations
Other Locations
Sweden
Ryhovs county hospital
RECRUITING
Jönköping
Region Skåne
RECRUITING
Lund
Region Örebro Län
RECRUITING
Örebro
Capio St Göran Hospital
RECRUITING
Stockholm
Karolinska University Hospital
RECRUITING
Stockholm
Södersjukhuset
RECRUITING
Stockholm
Umeå University hospital
RECRUITING
Umeå
Contact Information
Primary
Karin Söderkvist, MD,PhD
karin.soderkvist@umu.se
+46 90 7853222
Time Frame
Start Date: 2021-10-27
Estimated Completion Date: 2033-12
Participants
Target number of participants: 118
Treatments
Active_comparator: Standard of Care
ADT+ARPI to all patients and local RT +/- pelvic fields to de novo patients
Experimental: SBRT+Standard of Care
SBRT to all PSMA+ lesions in addition to SoC and salvage RT to the prostate bed +/- pelvic fields if recurrent post prostatectomy and PSMA-PET+ in the pelvis
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital, Umeå, Capio Sankt Görans Hospital, Ryhov County Hospital, Stockholm South General Hospital, Karolinska University Hospital, Region Skane, Region Ã-rebro County, Sahlgrenska University Hospital
Leads: Karin Soderkvist

This content was sourced from clinicaltrials.gov