Stereotactic Body Radiation for Prostate Oligometastases
Condition: Prostate Cancer; Oligometastases
MeSH terms: Prostatic Neoplasms
Intervention: SBRT
Intervention description: SBRT (1-5 fractions) will be administered.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Stereotactic Body Radiation Therapy; Stereotactic Ablative Radiotherapy; Oligometastasis

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.
    

Eligibility 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 Eastern Cooperative Oncology Group (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.