Radiologically Guided Biopsies of mCRPC

Inclusion Criteria:

- History of histologically confirmed prostate cancer. Patients without histologically
confirmed prostate cancer are eligible if both the treating physician and the study
PI agree that the patient's history is unambiguously indicative of advanced prostate
cancer (e.g. high PSA responsive to Androgen Deprivation Therapy.)

- Radiographic evidence of metastatic disease amenable to image-guided biopsy of a
metastatic site. Soft-tissue as well as bony metastatic lesions will be considered
acceptable. Patients with locally advanced disease only (where the biopsy would be of
a prostatic mass) are not eligible. Biopsy of newly emerging radiographic metastases
is desired and preferable to the biopsy of previously existing lesions whenever
possible.

- Platelets >75,000/μl within 14 days prior to biopsy

- PT or INR and a PTT < 1.5 times the institutional ULN within 14 days prior to biopsy.

- Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they
are deemed able to tolerate discontinuation of anti-coagulation for one week prior to
the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted
per local standard operating procedures, provided there is agreement regarding the
procedure between the treating physician, the interventional radiologist and the PI.

- Castrate levels of testosterone (testosterone <50ng/dL) within 28 days prior to
biopsy.

- Patients with significant congenital or acquired bleeding disorders (eg von
Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible.

- If no prior orchiectomy, medical castration therapy must continue while on study.

- PSA level obtained within 28 days prior to biopsy.

- Patients currently on first generation oral anti-androgens (flutamide, bicalutamide,
nilutamide) must have progressed after at least 4 weeks of anti-androgen
discontinuation.

- Patient's disease is currently progressing (in setting of testosterone < 50 ng/dl),
defined by any of the following criteria:

- PSA Progression: PSA level of at least 2 ng/ml which has risen on at least 2
successive occasions, at least one week apart. If the confirmatory PSA (#3) value is
less (i.e., #3b) than the screening PSA (#2) value, then an additional test for
rising PSA (#4) will be required to document progression for the purposes of
eligibility.

- Soft tissue progression: by RECIST v1.1

- Bone scan progression: the appearance of ≥ 2 new lesions. Symptomatic progression in
an area of radiologically evident diseas

- One of the following criteria must be met:

- Evidence of disease progression (as defined above) following treatment with at least
2 months of abiraterone acetate, enzalutamide, or ARN509 - based therapy.

- Enrollment on a high priority clinical trial conducted by the WCDT. Examples include
trials with biopsy obtained before abiraterone or enzalutamide therapy, and following
development of resistance to those agent(s). This list is maintained by the lead
site.

- Evidence of disease progression (as defined above) in patients with "aggressive
phenotype" mCRPC with at least one of the following clinical features

- Visceral or brain metastases

- Known small cell or neuro-endocrine subtypes (by IHC or serum markers)

- Primary ADT resistance defined as a nadir PSA of > 4 ng/dl after 7 months of primary
androgen deprivation (with Testosterone < 50 ng/dl.)

- Prior chemotherapy for Castration Resistant Prostate Cancer is not allowed

- Age > 18 yrs

- ECOG Performance status 0-3 (see appendix A)

- Ability to understand and the willingness to sign a written informed consent document