Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03361735

Sponsor: City of Hope Medical Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

Inclusion Criteria:

• Documented informed consent of participant and/or legally authorized representative
• Agreement to provide archival primary or metastatic tumor tissue if available
• Eastern Cooperative Oncology Group (ECOG) =< 2
• Life expectancy > 12 months
• Histologic diagnosis of prostate adenocarcinoma * Pure small cell carcinoma will be excluded; however, component of neuroendocrine /small cell differentiation will be allowed provided that adenocarcinoma constitutes majority of the tissue specimen
• Stage M1 * Metastatic disease can be documented by bone scan or computed tomography (CT) scan or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT or the combination of these tests
• Up to 4 metastatic lesions:
• Must have at least 1 bone lesion AND each non-visceral lesion should be less than 5 cm
• Visceral lesions will be limited to one lung lesion (< 2 cm) or one lymph node; no liver lesions allowed; lymph nodes allowed provided they are not in a field of prior radiation, and if amenable to SBRT (to be reviewed by principal investigator [PI])
• Two lesions can be in close proximity (i.e. within 5 cm of each other) if they meet radiation SBRT normal tissue toxicity requirements
• If have untreated primary prostate cancer: must undergo debulking prostatectomy
• If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI); retreatment to local residual-recurrent disease will result in potential eligibility to be reviewed by PI on a case-by-case basis
• Does not have castration resistant disease * Castration resistance defined as progression of disease despite serum testosterone level of < 50 ng/dL
• PSA >= 0.2 prior to start of androgen deprivation treatment
• Initiated 28 (+ 7) days of androgen deprivation therapy (ADT) prior to day 1 of protocol therapy * Only luteinizing hormone-releasing hormone (LHRH) agonist/antagonist treatment is considered ADT, bicalutamide or other antiandrogens used alone do not count
• May have received prior hormonal therapy in the context of definitive treatment of a primary tumor * Patients may have had one prior systemic non-chemotherapeutic treatment (i.e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiating agent) for recurrent or metastatic disease
• Must have refused standard of care chemotherapy for metastatic disease
• Recovered from all acute side-effects (except alopecia) related to previous systemic therapy
• Absolute neutrophil count (ANC) >= 1,500/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy) * NOTE: growth factor support is not permitted to normalize baseline ANC parameters, however subsequent growth factor administration is permitted as standard supportive care
• Platelets >= 100,000/mm^3 (to be performed within 14 days prior to day 1 of protocol therapy) * NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
• Hemoglobin (HgB) >= 9.0 g/dL (to be performed within 14 days prior to day 1 of protocol therapy) * NOTE: transfusion of blood products are not allowed to normalize baseline blood parameters, however subsequent transfusions are allowed per standard supportive care guidelines
• Total serum bilirubin =< 2 x upper limit of normal (ULN) (to be performed within 14 days prior to day 1 of protocol therapy)
• Aspartate aminotransferase (AST) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
• Alanine aminotransferase (ALT) =< 2.5 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
• Creatinine =< 2.5 mg/dL (to be performed within 14 days prior to day 1 of protocol therapy)

Exclusion Criteria:

• Prior radium Ra 223 dichloride
• Prior or concomitant chemotherapy for metastatic or recurrent disease with the following exceptions:
• Prior chemotherapy for local primary disease is permitted
• Bisphosphonates or receptor activator of nuclear factor kappa-Β (RANK) ligand inhibitors are allowed at doses and schedule consistent with the treatment or prevention of osteoporosis
• Prior radiation treatment for metastatic disease
• Concomitant radiation treatment to primary prostate site
• Orchiectomy
• Unstable medical comorbidities (i.e. uncontrolled cardiac comorbidities)
• Metastases that in the judgment of investigator-radiologist are not amenable to SBRT
• History of brain metastases or who currently have treated or untreated brain metastases
• Uncontrolled human immunodeficiency virus (HIV) infection
• Any other condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

View trial on ClinicalTrials.gov