RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers

• Status: Recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a Phase II non-blinded randomized study evaluating men with oligometastatic prostate cancer lesions randomized (1:1) to stereotactic ablative radiation therapy (SABR) versus SBAR + Radium-223. We are looking to determine the progression-free survival of men who have oligometastatic prostate cancer with at least one bone metastasis with stereotactic ablative radiation therapy (SABR) versus SABR + Radium-223.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 ≤ 5.0 cm or <250 cm3

• 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 be ≥ 18 years of age.

• 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 109/L, the platelet count ≥ 100 x 109/L and hemoglobin ≥ 10 g/dL.

• Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• 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 (greater >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.