Androgen Deprivation Therapy, Docetaxel, External Beam Radiation Therapy, and Stereotactic Body Radiation Therapy in Treating Patients with Prostate Cancer
- Willing and able to provide written informed consent
- Eastern cooperative group (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 (around 24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions; additionally, must be willing to be treated with a full two years 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)
- Prior local non-surgical therapy to treat prostate cancer (e.g. 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 has recently initiated hormone therapy (< 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 x 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 the efficacy of treating men with oligometastatic prostate cancer with the following therapy: (1st) systemic chemo-hormonal therapy with up to 6-months (around 24 weeks) of adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions.
II. Time to prostate specific antigen (PSA) recurrence.
Patients receive androgen deprivation therapy including leuprolide acetate intramuscularly (IM) or subcutaneously (SC), triptorelin IM, degarelix SC, or bicalutamide orally (PO) daily every 3 months for 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment with docetaxel repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Within 1-2 months, patients undergo external beam radiation therapy (EBRT) over 3 weeks. During or right after EBRT, patients then undergo stereotactic body radiation therapy (SBRT) over 1-5 weeks.
After completion of study treatment, patients are followed up every 3 and 6 months for 48 months.
Trial Phase Phase II
Trial Type Treatment
Johns Hopkins University / Sidney Kimmel Cancer Center
Kenneth James Pienta
- Primary ID J16151
- Secondary IDs NCI-2017-01674, CRMS-65410, IRB00120414
- Clinicaltrials.gov ID NCT03043807