Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer

Inclusion Criteria:

- Evaluate safety and tolerability of the combination of ADT and docetaxel for up to
three months following the last dose of docetaxel.

- High risk prostate cancer defined as extracapsular extension (cT3a) or seminal vesicle
involvement (cT3b) or invasion of adjacent structures (cT4), serum PSA >20 ng/mL or
Gleason score of 8 to 10 and/or regional lymph node or

- Oligometastatic disease defined as disseminated metastases beyond regional lymph nodes
that meet the following criteria:

- No visceral metastases

- Less than four bony metastases.

- Ability to comply with all study procedures and willingness to remain supine for 120
minutes during imaging.

- Patients must be informed of the experimental nature of the study and its potential
risks, and must sign an Institutional Review Board (IRB)-approved written informed
consent form indicating such an understanding.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.

- Patients must be considered candidates for prostatectomy as per standard of care.

- Adequate hematologic and renal function as evidenced by the following within 4 weeks
of day 1:

- ANC >1500/mm3

- Hemoglobin (HgB) >10.0 gr/dL independent of transfusion

- Platelets >100,000/mm3

- Creatinine <2.0 mg/dL

- Total bilirubin < Upper Limit of Normal (ULN)

- Estimated life expectancy of ≥ 12 months at screening.

- Throughout the study, patient and his female partner who is of childbearing potential
must use 2 acceptable methods of birth control (1 of which must include a condom as a
barrier method of contraception) from screening through 3 months after last dose of
study drug. Two acceptable methods of birth control thus include the following:

- A condom (barrier method of contraception) AND One of the following is required:

- Established and ongoing use of oral, injected, or implanted hormonal method of
contraception by the female partner

- Placement of an intrauterine device or intrauterine system by the female partner

- Additional barrier method: Contraceptive sponge or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the
female partner

- Tubal ligation in the female partner performed at least 6 months before screening

- Vasectomy or other procedure resulting in infertility (eg, bilateral
orchiectomy), performed at least 6 months before screening

- While receiving chemotherapy, the patient must use a condom if having sex with a
pregnant woman.

- Must agree not to donate sperm from first dose of study drug through 3 months after
the last dose of study drug.

Exclusion Criteria:

- Prior treatment for prostate cancer, including ADT, orchiectomy, antiandrogens,
ketoconazole, abiraterone acetate or enzalutamide.

- Prior radiation to the prostate.

- Use of other investigational agent for prostate cancer.

- No active secondary malignancy

- Chronic liver disease or abnormal liver function:

- Total bilirubin >ULN (NOTE: in subjects with Gilbert's syndrome, if total
bilirubin is >ULN, measure direct and indirect bilirubin and if direct bilirubin
is within normal range, subject may be eligible) or

- Alanine (ALT) or aspartate (AST) aminotransferase >2.0 x ULN or

- ALT or aspartate AST >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN.

- Peripheral neuropathy grade >1.

- Active cardiac disease defined as active angina, symptomatic congestive heart failure,
or myocardial infarction within the previous 6 months.

- Major surgery within 4 weeks before screening.

- Patients with known psychological or sociological conditions, addictive disorders or
family problems, which would preclude compliance with the protocol.

- Herbal supplements that have been shown to modulate testosterone or androgen signaling
(e.g. Saw Palmetto) are not allowed while on study.

- Subjects may not be enrolled concurrently on other treatment studies.

- Any concurrent disease, infection, or comorbid condition that interferes with the
ability of the patient to participate in the trial; places the patient at undue risk;
or complicates the interpretation of the data, in the opinion of the investigator or
medical monitor.