Prostate Cancer Clinical Trial
Official title:
SAXON-PC: A Phase II Randomized Trial of Stereotactic Body Radiation Therapy (SBRT) And Radium (Ra-223) Dichloride for Oligorecurrent, Non-castrate Resistant Prostate Cancer
Participants will either receive treatment with standard SBRT and the study drug Radium (Ra-223) dichloride, or standard SBRT alone.
Status | Recruiting |
Enrollment | 136 |
Est. completion date | November 12, 2027 |
Est. primary completion date | November 12, 2027 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado (Data Collection Only) | Aurora | Colorado |
United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
United States | Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack | New York |
United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | The primary outcome is to compare rates of composite PFS between the two treatment arms using bone scan imaging. A patient will be considered to have disease progression if any of the following events occur from the time of protocol randomization to date of last follow-up: a) PSA biochemical progression OR b) Radiographical progression OR c) clinical progression OR d) start of ADT OR e) death from any cause | 1 year |
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