Stereotactic Body Radiation for Prostate Oligometastases

• Status: Active, not recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment planning, SBRT (1-5 fractions) will be administered.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue 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 >1 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:

Leukocytes >2,000/μL Absolute Neutrophil Count >1,000/μL Platelets >50,000/μL

• 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.

• DCFPyL-PET/MRI or DCFPyL-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).

• Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).

• Patient receiving any other investigational agents.

• Patient is participating in a concurrent treatment protocol.

• 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.

• Liver Transaminases > 5-times the upper limit of normal.

• Prior salvage treatment to the primary prostate cancer or pelvis is allowed.

• Refusal to sign informed consent.