Clinical trial NCT05223803: TERPS Trial for De Novo Oligometastic Prostate Cancer
Official title: Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in De Novo OligometaStatic Prostate Cancer (TERPS) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Oligometastatic Disease
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 122
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.

   1. CT or MRI scan within 6 months of enrollment
   2. Bone scan within 6 months of enrollment
   3. 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)
2. Histologic confirmation of malignancy (primary or metastatic tumor).
3. Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
4. PSA \> 0.5 but \<100.
5. Patient must be ≥ 18 years of age.
6. Patient must have a life expectancy ≥ 12 months.
7. Patient must have an ECOG performance status ≤ 2.
8. Patient must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Castration-resistant prostate cancer (CRPC).
2. Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy
3. Spinal cord compression or impending spinal cord compression.
4. Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
5. Patient receiving any other investigational agents.
6. Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .
7. Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
8. No radiographical evidence of cranial metastasis.
9. Refusal to sign informed consent.

Primary outcomes:
measure: To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease
timeFrame: 5 years
measure: To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.
timeFrame: 1 year
measure: To assess time to progression
timeFrame: 5 years
measure: Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.
timeFrame: 5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Baltimore
country: United States
facility: Maryland Proton Treatment Center
state: Maryland
city: Baltimore
country: United States
facility: UMMC
state: Maryland
city: Bel Air
country: United States
facility: Upper Chesapeake Health
state: Maryland
city: Columbia
country: United States
facility: Central Maryland Radiation Oncology
state: Maryland
city: Glen Burnie
country: United States
facility: Baltimore Washington Medical Center
state: Maryland
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Jefferson Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Midlothian
country: United States
facility: Bon Secours Cancer Institute at St. Francis
state: Virginia
Study officials:
References: