- Histologically proven adenocarcinoma of the prostate with BRCAness (defined as a
deleterious alteration in one or more of the following genes: ATM, ATM, ATR, BARD1,
BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, ERCC3, FAM175A, FANCA, FANCL, GEN1, HDAC2,
MLH1, MRE11, NBN, PALB2, PPP2R2A, RAD51, RAD54L) from soft-tissue based genomic
testing or liquid biopsy based genomic testing.
- Rising PSA based on PCWG3 criteria without radiographic evidence of metastatic disease
as assessed by CT scans and technetium nuclear medicine bone scan. Subject must
demonstrate a PSA doubling time of ≤ 10 months.
- ECOG/Zubrod score of 0-2.
- Subject must not have received any prior systemic therapy for prostate cancer except
for adjuvant hormone treatment in the context of localized prostate cancer. Patients
may have not received ADT treatment longer than 24 months.
- Be 18 years old at the time the informed consent form is signed.
- Demonstrate adequate organ function as defined in the table in the protocol, all
screening labs should be performed within 28 days of treatment initiation.
- Highly effective barrier methods must be used with all sexual activity and
contraception methods must be practiced for all subjects throughout the study and for
at least 6 months after last rucaparib treatment administration if the risk of
conception exists (section 7.2).
- Recovery to baseline or Grade ≤ 1 CTCAE v5.0 from toxicities related to any prior
treatments (surgery, radiotherapy or other antineoplastic therapy), unless AE(s) are
clinically nonsignificant and/or stable on supportive therapy.
- Last dose of any antineoplastic therapy ≥ 2 weeks (including neoadjuvant chemotherapy,
radiation therapy, small molecule inhibitors, radiation, and/or other investigational
- Subject is participating in the Total Cancer Care study (IRB # 89989).
- Subject is able to provide informed consent and willing to sign an approved consent
form that conforms to federal and institutional guidelines.
- ADT therapy either by surgical castration or with GnRH agonist or antagonist or on
androgen synthesis blocker or androgen receptor antagonists previously for the
treatment of biochemically recurrent prostate cancer.
- Prior localized prostate cancer treatment with chemotherapy, radiation, antibody
therapy or other immunotherapy, gene therapy, vaccine therapy, or angiogenesis
- Arterial or venous thrombi (including cerebrovascular accident), myocardial
infarction, admission for unstable angina, cardiac angioplasty, or stenting within the
last 3 months prior to screening.
- Pre-existing duodenal stent, recent or existing bowel obstruction, and/or any
gastrointestinal disorder or defect that would, in the opinion of the Investigator,
interfere with absorption of rucaparib.
- Inability to swallow tablets.
- Evidence or history of bleeding disorder.
- Participation in another investigational drug trial within 14 days prior to Day 1 (or
5 times the half-life of the drug, whichever is longer) or exposure to more than three
new investigational agents within 12 months prior to Day 1.
- Acute illness (eg, nausea, vomiting, fever, diarrhea) within 14 days prior to Day 1,
unless mild in severity and approved by the Principal Investigator.
- Active second malignancy, with the exception of curatively treated non-melanoma skin
cancer, carcinoma in situ, or superficial bladder cancer with curative intent.
- Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide, or any
platinum based chemotherapy.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular
accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months
prior to enrollment), unstable angina, congestive heart failure (> New York Heart
Association Classification Class II), or serious cardiac arrhythmia requiring
- Other severe acute or chronic medical conditions including cardiovascular, endocrine,
neurologic, pulmonary or psychiatric conditions including recent (within the past
year) or active suicidal ideation or behavior; or laboratory abnormalities that may
increase the risk associated with study participation or study treatment
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the patient inappropriate for entry into this
- Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks
before first dose of study treatment. Complete wound healing from major surgery must
have occurred 1 month before first dose and from minor surgery (eg, simple excision,
tooth extraction) at least 28 days before first dose. Subjects with clinically
relevant ongoing complications from prior surgery are not eligible.