TERPS Trial for de Novo Oligometastic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Prostate radiation (XRT)
RadiationBoth arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
Systemic Therapy
DrugAll systemic therapy is provided as best prescribed for patient per their medical oncologist.
Stereotactic ablative radiation therapy (SABR)
RadiationSABR is delivered to those randomized to Arm 2.
Treatment groups
122 Participants
are divided into 2 treatment groupsGroup A: Best systemic therapy (BST) + primary prostate radiation (XRT)Active comparator 2 interventions
Group B: BST + XRT + SABR metastasis-directed therapy (MDT)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
2 yearsSecondary outcomes
1
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.
Time frame
5 years2
To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.
Time frame
1 year3
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).
Time frame
5 years4
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).
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov