a study of stereotactic body radiation therapy and radium (ra-223) dichloride in prostate cancer that has spread to the bones

Conditions: Prostate Cancer

Summary: participants will either receive treatment with standard sbrt and the study drug radium (ra-223) dichloride, or standard sbrt alone.


Eligibility criteria:
inclusion criteria: * biopsy proven prostate adenocarcinoma * ≥ 18 years old * primary prostate tumor must have been treated with prior prostatectomy or definitive radiotherapy * men with prior salvage radiotherapy to the prostate bed and/or locoregional lymph nodes are eligible assuming normalization of testosterone * negative multi-parametric mri and/or negative biopsy of the prostate (or prostate bed) within 60 days of enrollment * pre-enrollment imaging (any bone imaging modality per institutional standard of care) demonstrates oligometastatic disease with 1-3 discrete metastatic lesions of the bone performed within 60 days of study enrollment; screening psma pet confirming 1-3 sites of oligometastatic disease performed within 60 days of enrollment. * all bony oligometastatic sites must be deemed appropriate to receive 3 fraction sbrt to a dose of 9 gy x 3 at best judgment of treating radiation oncologist * prostate specific antigen (psa) ≥ 0.5 ng/ml but ≤ 50 ng/ml * patients may have had prior androgen deprivation therapy (adt) but must have normal testosterone levels (\>100 ng/dl) at time of enrollment; patients with baseline low testosterone but no adt exposure are eligible * eastern cooperative oncology group (ecog) performance status ≤ 2 * subjects who have not had surgical removal of their prostate and have a partner of child bearing potential must agree to use condoms beginning at the signing of the consent until at least 6 months after the last dose of study drug. because of the potential side effect on spermatogenesis associated with radiation, female partners of childbearing potential must agree to use a highly effective contraceptive method during and for 6 months after completing treatment. examples of highly effective contraception options for women include implantable uterine devices (hormonal or non-hormonal), oral, patch and parenteral contraceptives (when taken as prescribed). * adequate hematological, liver and renal function * absolute neutrophil count (anc) ≥ 1.5 x 10\^9/l * platelet count ≥ 100 x 10\^9/l * hemoglobin ≥ 10.0 g/dl * total bilirubin level ≤ 1.5 x institutional upper limit of normal (uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 x uln * creatinine ≤ 1.5 x uln with normal creatinine clearance * albumin \> 25 g/l * patient willing and able to comply with the protocol, including follow-up visits and examination exclusion criteria: * pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology * any metastatic site \>5 cm in maximum diameter * patients with documented castration resistant prostate cancer (crpc) * patients with any form of conventional, metabolic or molecular imaging (including pet imaging with psma, fluciclovine and/or fdg tracers) within 60 days of enrollment that demonstrate more than 3 discrete metastatic lesions * patients with evidence of nonpelvic lymph nodal or any visceral metastases * patients with evidence of progressing locoregional lymph nodes (prior lymphadenectomy or definitive/salvage rt to the pelvic lymph nodes is acceptable assuming no evidence of progression) * patients with documented or suspected impending significant spinal cord compression defined as epidural spinal cord compression (escc) grade 2 or higher using the bilsky scale * patients with parenchymal brain metastases * patient received any other investigational therapeutic agents or other anticancer therapeutics within 4 weeks prior to randomization * major surgery within 30 days prior to start of study drug * any prior systemic therapy with radionuclide agents (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188 or radium (ra-223) dichloride) for the treatment of bony metastases * fecal incontinence * history of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer * any other serious illness or medical condition, such as but not limited to: * any infection greater than national cancer institute common terminology criteria for adverse events (nci-ctcae) v 5.0 grade 2 * new york heart association (nyha) class iii or iv heart failure * crohn's disease or ulcerative colitis * bone marrow dysplasia or myelodysplastic syndrome

Keywords: prostate cancer sbrt non-castrate resistant prostate cancer oligorecurrent prostate cancer saxon-pc 21-213 memorial sloan kettering cancer center