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This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best systemic therapy (BST) + primary prostate radiation (XRT) | Active Comparator |
| |
| BST + XRT + SABR metastasis-directed therapy (MDT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate radiation (XRT) | Radiation | Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT. | Cross-over to the SABR MDT is allowed following failure. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease | Adverse events will be assessed at baseline, on treatment visit, and follow-up visit. | 5 years |
| To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease. |
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Inclusion Criteria:
Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.
Histologic confirmation of malignancy (primary or metastatic tumor).
Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
PSA > 0.5 but <100.
Patient must be ≥ 18 years of age.
Patient must have a life expectancy ≥ 12 months.
Patient must have an ECOG performance status ≤ 2.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zaker Rana, MD | Contact | 410-369-5200 | zaker.rana@umm.edu | |
| Nicole Helie | Contact | 410-328-6304 | nicole.helie@umm.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
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| Systemic Therapy | Drug | All systemic therapy is provided as best prescribed for patient per their medical oncologist. |
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| Stereotactic ablative radiation therapy (SABR) | Radiation | SABR is delivered to those randomized to Arm 2. |
|
| 1 year |
| To assess time to progression | Progression will be assessed for time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization to best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT). | 5 years |
| Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT. | EPIC quality of life tool will be used to assess quality of life following treatment. This survey will be completed at baseline and during follow-up visits. Averages will be taken for each section in the survey (Urinary Function, Bowel Function, Sexual Function, and Hormonal function). | 5 years |
| KU Medical Center- Cancer Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Maryland Proton Treatment Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| UMMC | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Upper Chesapeake Health | Recruiting | Bel Air | Maryland | 21014 | United States |
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| Central Maryland Radiation Oncology | Recruiting | Columbia | Maryland | 21044 | United States |
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| Baltimore Washington Medical Center | Recruiting | Glen Burnie | Maryland | 21061 | United States |
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| Sidney Kimmel Cancer Center at Jefferson Health | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Bon Secours Cancer Institute at St. Francis | Recruiting | Midlothian | Virginia | 23114 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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