TERPS Trial for de Novo Oligometastic Prostate Cancer

Study Overview
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Brief Summary
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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 three or fewer bone or soft tissue metastases.

Detailed Description
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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.

Official Title
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Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

Conditions
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Prostate Cancer, Oligometastatic Disease

Intervention / Treatment
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* Radiation: Prostate radiation (XRT)
* Drug: Systemic Therapy
* Radiation: Stereotactic ablative radiation therapy (SABR)


Participation Criteria
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Eligibility Criteria
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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. CT or MRI scan within 6 months of enrollment Bone scan within 6 months of enrollment Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone 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: Castration-resistant prostate cancer (CRPC). Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy Spinal cord compression or impending spinal cord compression. Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis). Patient receiving any other investigational agents. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist . Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR. No radiographical evidence of cranial metastasis. Refusal to sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best systemic therapy (BST) + primary prostate radiation (XRT)<br> | Radiation: Prostate radiation (XRT)<br>* Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.<br>Drug: Systemic Therapy<br>* All systemic therapy is provided as best prescribed for patient per their medical oncologist.<br>|
| Active Comparator: BST + XRT + SABR metastasis-directed therapy (MDT)<br> | Radiation: Prostate radiation (XRT)<br>* Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.<br>Drug: Systemic Therapy<br>* All systemic therapy is provided as best prescribed for patient per their medical oncologist.<br>Radiation: Stereotactic ablative radiation therapy (SABR)<br>* SABR is delivered to those randomized to Arm 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |