Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
NCT ID: NCT04599686
Last Updated: 2022-08-11
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2022-09-11
2025-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ADT
Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.
ADT
On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
Interventions
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ADT
On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
SBRT
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhang Huo Jun
Clinical Professor
Locations
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Changhai hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhao X, Wang T, Ye Y, Li J, Gao X, Zhang H. Stereotactic body radiotherapy (SBRT) versus androgen deprivation therapy (ADT) for oligometastatic prostate cancer: protocol for a prospective randomised control clinical trial. BMJ Open. 2022 Sep 30;12(9):e051371. doi: 10.1136/bmjopen-2021-051371.
Study Documents
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Other Identifiers
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Changhai Ho
Identifier Type: -
Identifier Source: org_study_id
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