Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

Launched by CHANGHAI HOSPITAL · Oct 22, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Stereotactic Body Radiotherapy (SBRT) for men with oligometastatic prostate cancer, which means they have a few cancer spots that have spread but not extensively. The goal is to see if SBRT, which uses targeted radiation to destroy cancer cells, is safe and effective without the usual hormone treatment called Androgen Deprivation Therapy (ADT). Participants will be randomly assigned to receive either SBRT or ADT shortly after their diagnosis, and the study will explore how well SBRT helps to control the cancer.

To join this trial, participants must be men aged 65 to 80 with confirmed prostate cancer and specific types and numbers of metastases, or cancer spread, that meet certain criteria. They should not have received previous treatments for these metastases and should generally be in good health. Those who take part can expect to receive either radiation or hormone therapy, with close monitoring of their health throughout the study. This trial is actively recruiting participants, and it could offer new insights into how to effectively treat prostate cancer that has started to spread.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 80 years old
• • Histologically confirmed adenocarcinoma of the prostate
• • Prostate cancer treated with curative intent (radical prostatectomy, primary radiotherapy, or a combination of both)
• • Ga-68 prostate-specific membrane antigen (PSMA) PET/CT evidence of one to three metastases (bone or lymph node) within 6 weeks of enrolment, if the position of oligometastases is judged by the doctor to be in the same radiotherapy area, the number of metastases can be appropriately increased to 5
• • Without ADT treatment
• • PSA\< 50ng/ml
• • ECOG performance status 0-2
• • Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
• Exclusion Criteria:
• • Any previous or ongoing treatment of oligometastases including radiotherapy, ADT, chemotherapy, focal treatment, etc.
• • Unstable lesions with spinal or long bone metastases
• • A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI
• • 4 metastases, or if the metastases are in the same radiotherapy area, ≥6 metastases
• • Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate
• • Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc.
• • Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc.
• • Patients who have participated in other clinical trials for less than three months
• • Unsuitable to participate in this clinical trial judged by the investigator