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Recruiting NCT05223803

TERPS Trial for de Novo Oligometastic Prostate Cancer

Phase II Interventional Prostate Cancer Oligometastatic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prostate radiation (XRT), Systemic Therapy, Stereotactic ablative radiation therapy (SABR).
Who it may be relevant to
Registry conditions: Prostate Cancer, Oligometastatic Disease. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Prostate radiation (XRT)
    Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.
  • Drug Systemic Therapy
    All systemic therapy is provided as best prescribed for patient per their medical oncologist.
  • Radiation Stereotactic ablative radiation therapy (SABR)
    SABR is delivered to those randomized to Arm 2.

Primary outcome measures

  • To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT. [Time frame: 2 years]
Secondary outcome measures (4)
  • To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease [Time frame: 5 years]
  • To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease. [Time frame: 1 year]
  • To assess time to progression [Time frame: 5 years]
  • Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT. [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • UC San Diego Moores Cancer Center — La Jolla
  • KU Medical Center- Cancer Center — Kansas City
  • Maryland Proton Treatment Center — Baltimore
  • UMMC — Baltimore
  • Upper Chesapeake Health — Bel Air
  • Central Maryland Radiation Oncology — Columbia
  • Baltimore Washington Medical Center — Glen Burnie
  • Sidney Kimmel Cancer Center at Jefferson Health — Philadelphia
  • … and 2 more centers

Identifiers

NCT: NCT05223803 · HP-00098826

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗