An interventional study of ADT and SBRT in Treatment, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
The aim of this study is to test the safety and feasibility of SBRT without ADT in oligometastatic prostate cancer in patients for whom the standard treatment is ADT, and to further explore how long only radiotherapy for oligometastases can prolong biochemical progression-free survival (bPFS). In this study, men with oligometastatic prostate cancer lesions will be randomized (1:1) to ADT versus SBRT. Within 6 weeks of the oligometastases diagnosis, ADT or SBRT (30-50Gy with 3-5 fractions) will be administered.
The oligometastatic disease state is an increasingly recognized phenomenon in prostate cancer. Ga-68 PSMA PET/CT has high accuracy in the diagnosis metastases from prostate cancer. In this protocol, pretreatment Ga-68 PSMA PET/ CT shall be performed in all patients.
ADT is considered standard of care treatment for advanced prostate cancer. But hormonal therapy can have side effects that greatly trouble men and lead to castration-resistant prostate cancer (CRPC). Any effort to delay the start of hormonal therapy would be an advantage to the patient. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. SBRT has been shown to be very effective on bone or lymph nodes metastases. Therefore, we are studying the safety and feasibility of SBRT on patients with five or fewer prostate cancer bone or lymph nodes metastases to determine if we can stall the use of hormonal therapy and/or prevent other site metastases from developing elsewhere in the body.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
80 years old
Exclusion Criteria:
A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI
Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.
Drug: ADT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
Radiation: SBRT
On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
1-year ADT-free survival of the experimental group
To assess ADT-free survival of the experimental group
Time frame: Assessment ADT-free survival of the experimental group at 1 year
The Probability of Radiotherapy-related Toxicity
Radiotherapy-related complications
Time frame: Assessment Toxicity at 1 year
The time from inception of the study to castration-resistant prostate cancer (CRPC)
the time from inception of the study to castration-resistant prostate cancer (CRPC)
Time frame: Assessment at 1 year
1-year Efficacy Biochemical Progression-free Survival (bPFS)
Biochemical Progression-free Survival (bPFS)
Time frame: 1 year
1-year Local Progression-Free-Survival(LPFS)
Local Progression-Free-Survival(LPFS)
Time frame: Assessment at 1 year
1-year Distant Metastasis Free Survival(DMFS)
Distant Metastasis Free Survival(DMFS)
Time frame: Assessment at 1 year
Plan to share: Yes — Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.
Supporting information: Study protocol
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Changhai Hospital