Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04599686|
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : August 11, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Treatment||Drug: ADT Radiation: SBRT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial|
|Estimated Study Start Date :||September 11, 2022|
|Estimated Primary Completion Date :||November 11, 2022|
|Estimated Study Completion Date :||October 1, 2025|
Active Comparator: ADT
Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.
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).
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 [ Time Frame: Assessment ADT-free survival of the experimental group at 1 year ]To assess ADT-free survival of the experimental group
- The Probability of Radiotherapy-related Toxicity [ Time Frame: Assessment Toxicity at 1 year ]Radiotherapy-related complications
- The time from inception of the study to castration-resistant prostate cancer (CRPC) [ Time Frame: Assessment at 1 year ]the time from inception of the study to castration-resistant prostate cancer (CRPC)
- 1-year Efficacy Biochemical Progression-free Survival (bPFS) [ Time Frame: 1 year ]Biochemical Progression-free Survival (bPFS)
- 1-year Local Progression-Free-Survival(LPFS) [ Time Frame: Assessment at 1 year ]Local Progression-Free-Survival(LPFS)
- 1-year Distant Metastasis Free Survival(DMFS) [ Time Frame: Assessment at 1 year ]Distant Metastasis Free Survival(DMFS)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04599686
|Contact: Huojun Zhang, PhDemail@example.com|
|Contact: Xianzhi Zhao, MDfirstname.lastname@example.org|
|Shanghai, Shanghai, China, 200433|
|Contact: Huojun Zhang, M.D. 021-31162222 email@example.com|
|Principal Investigator: Huojun Zhang, M.D.|
Please see the clinical trials NCT04599686
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Zhang Huo Jun, Clinical Professor, Changhai Hospital|
|Other Study ID Numbers:||
|First Posted:||October 23, 2020 Key Record Dates|
|Last Update Posted:||August 11, 2022|
|Last Verified:||December 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.|
|Time Frame:||Within 5 years after the publication of the study.|
|Access Criteria:||Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of oligometastatic prostate cancer treated with stereotactic body radiotherapy (SBRT) or androgen deprivation therapy (ADT). Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Oligometastatic Prostate Cancer
Genital Neoplasms, Male
Neoplasms by Site