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RecruitingPhase 2

TERPS Trial for de Novo Oligometastic Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether outcomes can be improved for people whose prostate cancer has spread when it is first diagnosed. It is for adults with a small number of areas of cancer spread, including at least one in a bone. The listing does not describe the treatment being tested.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have 1 to 3 areas of cancer spread in bone or soft tissue, including at least one in bone, with no symptoms. These must have developed in the past 6 months. Certain PET-CT scans may show up to 5 areas.
  • Have scans from within 6 months of joining: CT or MRI plus a bone scan, or an Axumin, choline, or PSMA PET-CT scan instead.
  • Have cancer confirmed by testing a tissue sample.
  • Prior whole-body treatment, including hormone-lowering treatment called ADT, is allowed within 9 months of joining.
  • Have a PSA blood test result above 0.5 and below 100.
  • Be expected to live at least 12 months and be able to care for yourself and be up and about at least half of your waking hours.
  • Be able to understand and willing to sign the study consent form.

Who can't join

  • Prostate cancer that keeps growing despite treatment to lower testosterone.
  • Past radiation to an overlapping area that makes more radiation unsafe.
  • Cancer pressing on the spinal cord, or likely to press on it soon.
  • Suspected cancer spread to the lungs or liver with an area larger than 10 millimeters.
  • Taking another experimental drug, or unable to receive any whole-body cancer treatment in the cancer doctor's judgment.
  • Unable to lie flat or tolerate PET/MRI, PET/CT, or focused radiation treatment called SABR.
  • No cancer spread to the skull seen on scans. This is listed as an exclusion in the source text; ask the study team to confirm.
  • Unwilling to sign the study consent form.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (10)

CA

KS

MD

PA

VA