Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
3.0 Eligibility
3.1 Registration – Inclusion Criteria
3.11 Age ≥18 years
3.12 The following disease characteristics:
3.121 Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer
3.122 3 or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and/or conventional imaging
3.123 Serum testosterone > 100ng/dL
3.14 ECOG Performance Status (PS) 0, 1 or 2 (Appendix I)
3.15 The following laboratory values obtained ≤15 days prior to registration:
Hemoglobin ≥8.0 g/dL
Absolute neutrophil count (ANC) ≥1500/mm3
Platelet count ≥80,000/mm3
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN (≤5 x ULN for patients with liver involvement)
Creatinine clearance for males =
(140-age)(weight in kg)(72)(serum creatinine inmgdL)
3.16 Provide written informed consent
3.17 Ability to complete questionnaire(s) by themselves or with assistance.
3.18 Willingness to provide mandatory blood specimens for correlative research (see Section 14.0).
3.19a Willingness to provide tissue specimens for correlative research (see Section 17.0).
3.19b Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
3.2 Registration – Exclusion Criteria
3.21 Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
3.22 Prior metastasis-directed therapy
3.23 Any of the following prior therapies:
Surgery ≤3 weeks prior to registration
Chemotherapy for prostate cancer at any time
Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years
3.24 Uncontrolled intercurrent non-cardiac illness including, but not limited to:
Ongoing or active infection
Psychiatric illness/social situations
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
Any other conditions that would limit compliance with study requirements
3.25 Receiving any other investigational agent which would be considered as a treatment for prostate cancer.
3.26 Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
3.27 Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
3.28 Uncontrolled intercurrent illness including, but not limited to:
ongoing or active infection
symptomatic congestive heart failure
unstable angina pectoris
cardiac arrhythmia
or psychiatric illness/social situations that would limit compliance with study requirements
3.29a Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
3.29b Other active malignancy ≤3 years prior to registration
EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cancer.
3.29c History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias