Improving treatment for prostate cancer with metastases at diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of adding stereotactic ablative radiation therapy (SABR) to the standard treatment regimen for prostate cancer patients with newly diagnosed oligometastatic disease. Participants will receive either the standard of care treatment, which includes systemic therapy and primary prostate radiation, or the same treatment plus SABR targeting metastatic lesions. The study will also assess the impact of these treatments on recurrence rates, circulating tumor cells, gut bacteria, and quality of life. The trial is designed to provide insights into optimizing treatment strategies for this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• KU Medical Center- Cancer Center
  Kansas City, Kansas, United States Recruiting
• Maryland Proton Treatment Center
  Baltimore, Maryland, United States Recruiting
• Ummc
  Baltimore, Maryland, United States Recruiting
• Upper Chesapeake Health
  Bel Air, Maryland, United States Recruiting
• Central Maryland Radiation Oncology
  Columbia, Maryland, United States Recruiting

Study contacts

• Study coordinator: Zaker Rana, MD
• Email: zaker.rana@umm.edu
• Phone: 410-369-5200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

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• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.