Overview

A Study of Stereotactic Body Radiation Therapy and Radium (Ra-223) Dichloride in Prostate Cancer That Has Spread to the Bones

Status:
Recruiting
Trial end date:
2024-11-12
Target enrollment:
0
Participant gender:
Male
Summary
Participants will either receive treatment with standard SBRT and the study drug Radium (Ra-223) dichloride, or standard SBRT alone.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
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

- No clinical evidence of local recurrence by digital rectal examination

- Negative multi-parametric MRI and/or negative biopsy of the prostate (or prostate bed)
within 2 months 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 90 days of study enrollment; screening sodium fluoride PET confirming
1-3 sites of oligometastatic disease performed within 30 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 3 months 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