Stereotactic Body Radiation for Prostate Oligometastases (ORIOLE)
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|ClinicalTrials.gov Identifier: NCT02680587|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2016
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Oligometastases||Radiation: SBRT Drug: DCFPyL-PET/MRI or -PT/CT Other: Observational (no SBRT)||Phase 2|
This research is being done to determine if we can improve the outcome of prostate cancer patients who have failed primary treatment — surgery or local radiation to the prostate — and have 3 or fewer bone metastases. Patients with metastatic prostate cancer disease will usually be placed on hormonal therapy which can work well for a period of time, but hormonal therapy can have side effects that greatly trouble men. Any effort to delay the start of hormonal therapy would be an advantage to the patient. Radiation treatment usually takes many weeks to deliver and is not given in a high enough doses to metastases to prevent them from coming back locally. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. Stereotactic body radiation has been shown to be very effective on bone metastases. Therefore, we are studying the effects of stereotactic body radiation treatment on patients with five or fewer prostate cancer bone metastases to determine if we can stall the use of hormonal therapy and/or prevent other bone metastases from developing elsewhere in the body.
Additionally, fundamental analysis of the oligometastatic state with be achieved through correlation with investigational DCFPyL-PET imaging, which can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.
Specifically, 54 men with biochemically recurrent, oligometastatic prostate adenocarcinoma will be accrued across 3 centers in the United States. Patients were stratified by primary intervention (surgery vs radiotherapy), prior hormonal therapy, and PSA doubling time, then randomized 2:1 to SBRT or observation. The primary clinical endpoint is progression at 6 months from randomization with the hypothesis that SBRT to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints include local control at 6 months post-SBRT, SBRT-associated toxicity and quality of life, and ADT-free survival (ADT-FS).
Alterations in the biology of the oligometastatic state induced by stereotactic ablative radiotherapy (SABR) will be investigated using leading-edge correlatives, including: analysis of circulating tumor cells (CTCs; Epic Sciences, San Diego, CA), deep sequencing of circulating tumor DNA (ctDNA) using Cancer Personalized Profiling by deep sequencing (CAPP-Seq) to non-invasively assess tumor burden, and ImmunoSEQ profiling of T-cell repertoires to elucidate the immunological response to SABR (Adaptive Technologies, Seattle, WA). Lastly, the use of the Color Genomics platform (Burlingame, CA), a hereditary cancer assay assessing pathogenic mutations in 30 cancer predisposition genes that account for >90% of the germline mutations known to occur in men with castrate resistant metastatic prostate cancer (mCRPC), will help inform and allow for efforts to advance a more personalized medicine approach to tailor screening and therapies in these men.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Observation Versus Stereotactic Ablative RadiatIOn for OLigometastatic Prostate CancEr (ORIOLE) Trial|
|Actual Study Start Date :||April 28, 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||October 2022|
Placebo Comparator: Observational (no SBRT)
Evaluating men with oligometastatic prostate cancer lesions randomized to observation
Other: Observational (no SBRT)
These patient will not receive SBRT. They will be observed.
Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).
SBRT (1-5 fractions) will be administered.
DCFPyL-PET/MRI or -PT/CT Estimate the proportion of DCFPyL-PET/MRI or -PET/CT positive sites that are positive for new or progressive metastatic disease by bone scan at 6-months from SBRT and vice versa
Drug: DCFPyL-PET/MRI or -PT/CT
Estimate the proportion of DCFPyL-PET/MRI or -PET/CT positive sites that are positive for new or progressive metastatic disease by bone scan at 6-months from SBRT and vice versa
- Time to progression [ Time Frame: 6 months ]To radiographically determine the proportion of men who have progressed after 6 months from randomization to observation versus SBRT who have oligometastatic prostate cancer.
- Change in rate of toxicity [ Time Frame: 6 months ]To assess the toxicity of SBRT in patients with oligometastatic disease via blood test and physicals
- time to local progression [ Time Frame: 6 months ]To determine radiographically local control at 6-months after SBRT in patients with oligometastatic disease.
- Time to progression free survival [ Time Frame: 6 months ]To assess progression free survival (PFS) radiographically after randomization to observation versus SBRT.
- Rate of change in survival of two groups (observational versus SBRT) [ Time Frame: 6 months ]To assess ADT-free survival after randomization to observation versus SBRT via blood tests
- Rate of change in quality of life of patients receiving SBRT versus people being observed. [ Time Frame: 5 months ]To assess quality of life following completion of SBRT via questionnaires.
- Rate of change of DCFPyL=PET/MRI positive lesions of patients treated with SBRT versus untreated observed patients. [ Time Frame: 6 months ]Estimate the proportion of DCFPyL-PET/MRI or -PET/CT positive sites that are positive for new or progressive metastatic disease by bone scan/CT at 6-months following SBRT and vice versa.
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): NCT02680587
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Phuoc Tran, M.D.||Johns Hopkins Department of Radiation Oncology and Molecular Radiation Sciences|