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Title:
A phase II study of definitive therapy for newly diagnosed men with oligometastatic prostate cancer
Protocol Number:
J1618
Phase:
Phase II
Physician:
Kenneth Pienta
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To assess the safety of treating men with oligometastatic prostate cancer with 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. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.
Eligibility:
Inclusion Criteria:1.Willing and able to provide written informed consent.2.Age equal to 18 years3.Eastern cooperative group (ECOG) performance status equal to 24.Documented histologically confirmed adenocarcinoma of the prostate5.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.6.Oligometastatic prostate cancer: Stage T1-4, N0-1 and M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or PET scan)7.Able to swallow the study drugs whole as tabletsExclusion Criteria:1.Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)2.Prior therapy to a metastatic site.3.Prior or ongoing systemic therapy for prostate cancer including, but not limited to:a.Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)b.CYP-17 inhibitors (e.g. ketoconazole)c.Antiandrogens (e.g. bicalutamide, nilutamide)d.Second generation antiandrogens (e.g. enzalutamide, abiraterone)e.Immunotherapy (e.g. sipuleucel-T, ipilimumab)f.Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone therapy was recently initiated ( less than 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.4.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.5.Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.6.Abnormal bone marrow function [absolute neutrophil count (ANC) less than 1500/mm3, platelet count less than 100,000/mm3, hemoglobin less than 9 g/dL]7.Abnormal liver function (bilirubin greater than ULN; AST, ALT greater than 2.5 x upper limit of normal)8.Creatinine clearance of equal to 30 mL/min. CrCl should be calculated suing the Cockcroft-Gault formula.9.PT, INR equal to 1.5 x ULN (except if on therapeutic anticoagulation in which case the patient can be enrolled if stable and anti-coagulation levels are appropriate for their condition on good clinical practice).10.Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.11.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 PI.
Treatment:
Neoadjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel therapy, patients with a PSA response of at least a 50% decrease from baseline, will proceed to maximum consolidative therapy.Local consolidation (month 7 though ~11): After completion of neoadjuvant therapy, the men will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant radiation therapy (RT). After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites.Systemic consolidation: Patients will continue on androgen deprivation for a total of 1 year. They will be followed clinically and monitored with serum testosterone and PSA until 2-years after completion of systemic consolidation. Androgen blockade will be the same throughout the course of treatment.
Population:
Adult
Last Update
03/05/2019 05:03 AM