Androgen Deprivation Therapy, Docetaxel, External Beam Radiation Therapy, and Stereotactic Body Radiation Therapy in Treating Patients with Prostate Cancer
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Maryland
Baltimore
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
I. Safety.
II. Time to prostate specific antigen (PSA) recurrence.
OUTLINE:
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
Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center
Principal Investigator
Kenneth James Pienta
- Primary ID J16151
- Secondary IDs NCI-2017-01674, CRMS-65410, IRB00120414
- Clinicaltrials.gov ID NCT03043807