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

Launched by KARIN SODERKVIST · Jul 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation therapy called Metastasis Directed Stereotactic Body Radiotherapy (MD-SBRT) for men with hormone-sensitive prostate cancer that has spread to a few specific areas, known as oligometastatic disease. The trial aims to see if adding MD-SBRT to standard treatment can help patients live longer without their cancer getting worse. Participants will be randomly assigned to either receive MD-SBRT along with standard treatment or just standard treatment alone.

To be eligible for the trial, participants must have confirmed prostate cancer with 1 to 3 metastases found through a special imaging test called PSMA-PET/CT. They should be in good overall health and able to give informed consent. Throughout the study, participants will be monitored for side effects and how well the treatment works over several years. This trial is currently recruiting and aims to include about 118 patients, providing a valuable opportunity to contribute to research that could improve treatment options for prostate cancer.

Gender

MALE

Eligibility criteria

• 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