Gender
Male
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Willing and able to provide, or have a legally authorized representative provide,
written informed consent and HIPAA authorization for the release of personal health
information. A signed informed consent must be obtained before screening procedures
are performed.
- Histologically confirmed prostate cancer.
- High volume metastatic disease (defined as the presence of visceral metastases or ≥3
bone lesions).
- ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed
(i.e. ADT used previously in courses of radiation).
- Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if
they have not undergone orchiectomy.
- ECOG Performance Status 0 or 1 (see Appendix A)
- Patient has adequate bone marrow and organ function as defined by the following
laboratory values:
- Absolute neutrophil count ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Hemoglobin ≥ 9 g/dl
- Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min
- In the absence of liver metastases, alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) <2.5 x ULN. If the patient has liver
metastases, ALT and AST <5 x ULN
- Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x
ULN in patients with well-documented Gilbert's Syndrome.
- Sexually active males must use a condom during intercourse while taking study drugs
and for 30 days after stopping treatment and should not father a child in this
period. A condom is required to be used also by vasectomized men in order to prevent
delivery of the drug via seminal fluid. Fertile males must use a condom with
spermicide (double barrier method).
- Age ≥ 18 years
Exclusion Criteria:
- Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
- Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks
- Radiation therapy (including palliative radiotherapy to a metastatic lesion) within
14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or
neurosurgery) within 28 days of the date of the first dose.
- Other systemic therapies for prostate cancer within 28 days or 5 half-lives,
whichever is shorter, prior to day 1 of chemotherapy (with the exception of
anti-androgens like bicalutamide).
- PSA <2.0 ng/mL at diagnosis.
- If present, peripheral neuropathy must be ≤ Grade 1
- Patients with an active second malignancy that could, in the investigator's opinion,
potentially interfere with the patient's ability to participate and/or complete this
trial.
- Patients with central nervous system (CNS) involvement unless they meet ALL of the
following criteria:
- At least 4 weeks from prior therapy completion (including radiation and/or
surgery) prior to starting the study treatment
- Clinically stable CNS tumor at the time of screening.
- Baseline screening for CNS metastases is not required unless presence of signs
and/or symptoms of involvement
- Patients with severe psychiatric illness/social situations that would limit
compliance with study requirements in the judgment of treating investigator.
- Patient has a history of non-compliance to medical regimen or inability to grant
consent.