A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Leuprolide Acetate; Docetaxel; Bicalutamide; Radiation; Abiraterone Acetate
Intervention description: 22.5mg by intramuscular (IM) injection every 3 months; 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.; bicalutamide (Casodex) 50mg by mouth daily; Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.; Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
Intervention MeSH terms: Docetaxel; Leuprolide; Abiraterone Acetate; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: prostatectomy; androgen deprivation; chemotherapy; radiation

Summary:

      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 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. The men will receive a total of 2 years of androgen deprivation.
      Androgen blockade will be the same throughout the course of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing and able to provide written informed consent.

          2. Age ≥ 18 years

          3. Eastern cooperative oncology group (ECOG) performance status ≤2

          4. Documented histologically confirmed adenocarcinoma of the prostate

          5. 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 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.

          6. 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 seen on bone scan,
             contrast enhanced CT scan, or positron emission tomography PET scan)

        Exclusion Criteria:

          1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy,
             brachytherapy)

          2. Prior therapy to a metastatic site.

          3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

               1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)

               2. CYP-17 (cytochrome P450 17α-hydroxy/17,20-lyase) inhibitors (e.g. ketoconazole)

               3. Antiandrogens (e.g. bicalutamide, nilutamide)

               4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)

               5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)

               6. Chemotherapy (e.g. docetaxel, cabazitaxel) *Note: may be enrolled if hormone
                  therapy was recently initiated (<90 days duration)). In the event that hormone
                  therapy was initiated prior to study enrollment, the clock for 2 years 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)<1500/mm3, platelet
             count <100,000/mm3, hemoglobin <9 g/dL]

          7. Abnormal liver function (bilirubin >ULN ( upper limit of normal); AST (aspartate
             aminotransferase), ALT (alanine transaminase) > 2.5 x upper limit of normal)

          8. Creatinine clearance of ≥ 30 mL/min. CrCl (Creatinine clearance) should be calculated
             suing the Cockcroft-Gault formula.

          9. Active cardiac disease defined as active angina, symptomatic congestive heart failure,
             or myocardial infarction within previous six months.

         10. 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.