A Trial of RAdium-223 and SABR Versus SABR for oligomEtastatic Prostate caNcerS (RAVENS)

Overview

About this study

The primary purpose of this study is to assess progression-free survival of men who have oligometastatic prostate cancer after randomization to stereotactic ablative radiation therapy (SABR) versus SABR and Radium-223.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male patient must be ≥ 18 years of age.
    1.  
  • Patient must have at least one and up to three asypmtomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are ≤ 5.0 cm or < 250 cm^3 as seen on either CT/MRI scan and/or bone scan. Up to five lesions are allowed on advanced funcitonal imaging such as fluciclovine (Axumin), choline or 18F-DCFPyL (“PyL”) PET-CT scan. (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and/or bone scan).
  • Patient must have had their primary tumor treated with surgery and/or radiation.
  • Histologic confirmation of malignancy (primary or metastatic tumor).
  • PSADT < 15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA > 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer Prediction Tool will be used. It can be found at the following web site: https://www.mskcc.org/nomograms/prostate/psa-doubling-time.
  • Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer.  Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
  • PSA > 0.5  but < 50.
  • Testosterone > 125 ng/dL.
  • Patient must have a life expectancy ≥ 12 months.
  • Patient must have an ECOG performance status ≤ 2.
  • Patient must have normal organ and marrow function as defined as:
    • Before the first administration of Xofigo, the absolute neutrophil count (ANC) should be ≥ 1.5 x 10^9/L;
    • The platelet count ≥ 100 x 10^9; and
    • Hemoglobin ≥ 10 g/dL.
  • Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Patient is under 18 years of age.
  • No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
  • PSMA-PET/MRI or PSMA-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan.
  • Castration-resistant prostate cancer (CRPC).
  • Spinal cord compression or impending spinal cord compression.
  • Suspected pulmonary and/or liver metastases (> 10 mm in largest axis).
  • Patient receiving any other investigational agents.
  • Patient receiving abiraterone and prednisone.
  • Patient is participating in a concurrent treatment protocol.
  • Serum creatinine > 3 times the upper limit of normal.
  • Total bilirubin > 3 times the upper limit of normal.
  •  Liver Transaminases > 5-times the upper limit of normal.
  •  Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
  •  Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
  •  Refusal to sign informed consent.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Stish, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20509425

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