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

RecruitingNAAges 18 Years - anyMaleKarin Soderkvist
NCT04983095 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 balanc

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Histologically confirmed prostate cancer (ICD-O-3 C61) 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: 1. Castration resistant prostate cancer (progression with castrate levels of testosterone) 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
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What it tests

  • stereotactic body radiotherapy
  • androgen deprivation therapy
  • Radiotherapy
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Where

7 sites
Region Skåne
Lund, Sweden
Capio St Göran Hospital
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umeå University hospital
Umeå, Sweden
Ryhovs county hospital
Jönköping, Sweden
Region Örebro Län
Örebro, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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