Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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
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)
- Calculated creatinine clearance ≥30 ml/min using the Cockcroft-Gault formula:
- Creatinine clearance for males = (140 − age)(weight in kg) (72)(serum creatinine in mg⁄dL)
- Creatinine clearance for females = (140 − age)(weight in kg) (0.85) (72)(serum creatinine in mg⁄dL)
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
3.19a Willingness to provide tissue specimens for correlative research
3.19b Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
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
- Pregnant persons
- Nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/1/2024. Questions regarding updates should be directed to the study team contact.