Hormone Therapy and Docetaxel before Surgery and Radiation Therapy in Treating Patients with Newly Diagnosed Oligometastatic Prostate Cancer
- Willing and able to provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Documented histologically confirmed adenocarcinoma of the prostate
- Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions; additionally, must be willing to be treated with a full year of androgen deprivation
- Oligometastatic prostate cancer: stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions-including bone lesions and non-regional lymph nodes)
- Able to swallow the study drugs whole as tablets
- Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
- Prior therapy to a metastatic site
- Prior systemic therapy for prostate cancer including, but not limited to: * Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix) * CYP-17 inhibitors (e.g. ketoconazole) * Antiandrogens (e.g. bicalutamide, nilutamide) * Second generation antiandrogens (e.g. abiraterone, enzalutamide) * Immunotherapy (e.g. sipuleucel-T, ipilimumab) * Chemotherapy (e.g. docetaxel, cabazitaxel) * Note: may be enrolled if hormone therapy was recently initiated of any kind (< 90 days duration); in the event that hormone therapy was initiated prior to study enrollment, the clock for 1 year of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment
- Ongoing systemic therapy for prostate cancer including, but not limited to: * Immunotherapy (e.g. sipuleucel-T, ipilimumab) * Non-protocol prescribed chemotherapy (e.g. cabazitaxel)
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
- Absolute neutrophil count (ANC) < 1500/mm^3
- Platelet count < 100,000/mm^3
- Hemoglobin < 9 g/dL
- Bilirubin > upper limit of normal (ULN)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >= 2.5 upper limit of normal
- Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months
- Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin; other malignancies that are considered to have a low potential to progress may be enrolled at discretion of principal investigator (PI)
I. To assess efficacy of the following therapy: (1st) systemic chemo-hormonal therapy with 6-cycles (~24 weeks) of neoadjuvant androgen deprivation and chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and then (3rd) consolidative stereotactic radiation to oligometastatic lesions.
II. Time to prostate specific antigen (PSA) recurrence.
NEOADJUVANT TREATMENT: Patients receive leuprolide acetate intramuscularly (IM) or subcutaneously (SC) every 3 months for up to 6 months. Patients also receive docetaxel intravenously (IV) over 60 minutes on day 1. Treatment with docetaxel repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
LOCAL CONSOLIDATION: 1.5 months after final cycle of chemotherapy, patients undergo radical prostatectomy. Beginning 3 months after surgery, patients may undergo radiation therapy over 3 weeks. Beginning 2-3 months after surgery, patients undergo SBRT to metastatic sites in 1-5 weeks.
SYSTEMIC CONSOLIDATION: Patients continue to receive leuprolide acetate IM or SC every 3 months for 1 year.
After completion of study treatment, patients are followed up every 3-6 months for 36 months.
Trial Phase Phase II
Trial Type Treatment
Johns Hopkins University / Sidney Kimmel Cancer Center
Kenneth James Pienta
- Primary ID J1618
- Secondary IDs NCI-2016-00836, CRMS-63459, IRB00070003
- Clinicaltrials.gov ID NCT02716974