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Total Eradication following Radiation for the Treatment of Oligometastatic Prostate Cancer, TERPS Study
Trial Status: enrolling by invitation
This phase II trial compares the effect of standard of care treatment to standard of care treatment in combination with stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT) in patients with prostate cancer that has spread from where it first started (primary site) to other places in the body. For patients with metastatic prostate cancer disease recurrence, the established approach is to offer androgen deprivation therapy (ADT) which improves survival but inevitably leads to castration resistance, and can be associated with significant adverse effects. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Inclusion Criteria
Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone, soft tissue, or extra-pelvic nodal region that are seen on imaging. A nodal lesion is defined to include nodal conglomerates located in the same nodal chain such that they can be treated in one SABR field. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or prostate-specific membrane antigen (PSMA) positron emission tomography and computerized tomography (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 12-months of enrollment.
Prostate-Specific Antigen (PSA) > 0.5 but < 150
Patient must be >= 18 years of age.
Patient must have a life expectancy >= 12 months.
Patient must have an Eastern Cooperative Oncology Group (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 intracranial 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.
Refusal to sign informed consent.
Additional locations may be listed on ClinicalTrials.gov for NCT05223803.
I. To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with best systemic therapy (BST) + primary prostate radiation (XRT) versus BST+XRT + stereotactic ablative radiation (SABR) metastasis-directed therapy (MDT).
SECONDARY OBJECTIVES:
I. To assess the toxicity of SABR MDT in patients with new (de novo) oligometastatic disease.
II. To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.
III. To assess 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).
IV. To assess quality-of-life following completion of SABR MDT.
CORRELATIVE OBJECTIVES:
I. To enumerate circulating tumor cells (CTC) using HD-CTC platforms at baseline and 6 month follow-up.
II. To bank plasma at baseline, end of treatment (EOT), 3 month, and 12 month follow-up.
III. To quantitatively sequence T-cell receptor (TCR) repertoires using peripheral blood monocytes and the ImmunoSEQ platform at baseline and 3 month follow-up.
IV. To determine frequency of germline deoxyribonucleic acid (DNA) repair mutations in the oligometastatic state.
V. To discover imaging features from baseline and most proximal failure-associated diagnostic imaging studies.
VI. To discover imaging features from cone-beam computed tomography (CT) imaging obtain during SABR MDT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo best systemic therapy (BST) and primary prostate radiation (XRT) on study. Patients also undergo bone scan and CT/magnetic resonance imaging (MRI) and undergo collection of blood and rectal samples on throughout the trial. Patients may optionally undergo hyperpolarized carbon C 13 pyruvate (hyperpolarized 13C pyruvate) MRI throughout the study.
ARM II: Patients undergo BST, XRT, and stereotactic ablative radiation metastasis-directed therapy (SABR MDT) on study. Patients also undergo bone scan and CT/MRI and undergo collection of blood and rectal samples on throughout the trial. Patients may optionally undergo cone-beam CT and 13C pyruvate MRI throughout the study.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
