Phase II Randomized Observation Versus Stereotactic Ablative RadiatIOn for OLigometastatic Prostate CancEr (ORIOLE) Trial


Condition: Prostate Cancer, Oligometastases

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02680587

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: Male

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.

View trial on ClinicalTrials.gov