Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
NCT ID: NCT04983095
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2021-10-27
2033-12-31
Brief Summary
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* 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.
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Detailed Description
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Study intervention (arm A): MD-SBRT to all PSMA-PET/CT positive metastatic target volume(s) with 30 Gy in 3 fractions or 40 Gy in 5 fractions in addition to SoC. For recurrent patients post prostatectomy with PSMA-PET-positive finding at prostate bed +/- regional lymph nodes (without prior local RT) salvage RT +/-pelvic fields with SIB to the PSMA+ GTV is to be delivered (sum of SBRT-targets maximum 3).
Screening procedure:Inclusion/exclusion criteria evaluation including evaluation of feasibility of SBRT to all positive lesions on PSMA-PET/CT performed within approx. 30 days of randomization.
Study specific procedure: Recording/collecting of baseline data including baseline PROM and pre-ADT testosterone and PSA. Standard treatment with ADT administered at randomization to all study patients. Abiraterone is initiated within 8 weeks of study entry. Start of MD-SBRT within approx. 28 days of randomization to patients in arm A. Additional RT as specified in study intervention started within 90 days. Follow up according to protocol, minimum 60 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
ADT+ARPI to all patients and local RT +/- pelvic fields to de novo patients
androgen deprivation therapy
Medical castration and next-generation Hormonal Agent along with radiotherapy to the prostate in de novo oligometastatic prostate cancer
Radiotherapy
RT to the prostate for de novo patients
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
stereotactic body radiotherapy
30 Gy in 3 fractions alternatively 40 Gy in 5 fractions delivered with stereotactic radiotherapy-principles
androgen deprivation therapy
Medical castration and next-generation Hormonal Agent along with radiotherapy to the prostate in de novo oligometastatic prostate cancer
Radiotherapy
RT to the prostate for de novo patients
Interventions
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stereotactic body radiotherapy
30 Gy in 3 fractions alternatively 40 Gy in 5 fractions delivered with stereotactic radiotherapy-principles
androgen deprivation therapy
Medical castration and next-generation Hormonal Agent along with radiotherapy to the prostate in de novo oligometastatic prostate cancer
Radiotherapy
RT to the prostate for de novo patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. WHO/ECOG performance status 0-1
3. 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
4. Willing and able to provide informed consent-
Exclusion Criteria
2. Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2 weeks of study entry)
3. Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician
4. Life expectancy \<3 years by any reason, including concomitant or previous malignancies
5. Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate)
6. \> 3 PSMA-PET/CT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or regional lymph node metastasis in recurrent patients)
7. PSMA-PET verified metastases other than skeletal or lymph nodes
8. Metastases in base of scull and/or calotte
9. Any target lesions not treatable with image guided RT (IGRT) due to overlap with previous RT fields or exceeded dose constraint to OAR(s) as specified in study protocol
18 Years
MALE
No
Sponsors
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University Hospital, Umeå
OTHER
Karolinska University Hospital
OTHER
Stockholm South General Hospital
OTHER
Region Skane
OTHER
Capio Sankt Görans Hospital
UNKNOWN
Region Ã-rebro County
UNKNOWN
Ryhov County Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Karin Soderkvist
OTHER
Responsible Party
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Karin Soderkvist
Senior Consultant, PhD
Principal Investigators
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Karin Söderkvist
Role: PRINCIPAL_INVESTIGATOR
Region Västerbotten, Umeå University
Locations
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Region Skåne
Lund, Lund, Sweden
Capio St Göran Hospital
Stockholm, Region Stockholm, Sweden
Södersjukhuset
Stockholm, Region Stockholm, Sweden
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Umeå University hospital
Umeå, Umea, Sweden
Ryhovs county hospital
Jönköping, , Sweden
Region Örebro Län
Örebro, Örebro County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Official site for clinical trials by Swedish Regional Cancer Centres in Collaboration
Other Identifiers
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METRO_vers1
Identifier Type: -
Identifier Source: org_study_id
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