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Predicting Response to Platinum Chemotherapy in Metastatic Castration Resistant Prostate Ca(mCRPC)Using a Genomic Signature for "BRCAness": A Phase II Prospective Open Label Clinical Trial of Satraplatin in Men With mCRPC Who Have Progressed on Docetaxel

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Predicting Response to Platinum Chemotherapy in Metastatic Castration Resistant Prostate Ca(mCRPC)Using a Genomic Signature for "BRCAness": A Phase II Prospective Open Label Clinical Trial of Satraplatin in Men With mCRPC Who Have Progressed on Docetaxel

We will be developing a genomic based signature of "BRCAness" based on literature of
genomic signatures from women with breast cancer and germline BRCA mutations.The "BRCAness"
breast cancer signature will differentiate germline BRCA 1/2 breast cancers from standard
estrogen-receptor (+) breast cancers. We will obtain a library of genomic signatures
Recently these techniques have been used to develop a transcriptional "signature" for
androgen receptor (AR) activity in men with CRPC(Castration Resistant Prostate Cancer). The
investigator will apply the "BRCAness" breast cancer signature to pathological prostate
cancer specimens to determine the percentage of patients in the overall prostate cancer
population that express this signature, as well as the clinical and histological phenotype
of this population.

This novel prostate cancer "BRCAness" signature will be developed over a period of 4-6
months. This "BRCAness" signature has not previously been evaluated in prostate cancer
patients and would be expected, based on known characteristics of BRCA mutant breast and
ovarian cancers, to be more platinum-responsive. Relevant clinical data, including
histology, grade, stage, size of residual tumor, recurrence, and survival, will be obtained
from outpatient and inpatient charts to perform subsequent correlative studies.

All patients enrolled in the phase II clinical trial with satraplatin will have
pre-treatment biopsies of metastatic sites. All of the specimens will be frozen, batched and
stored as previously described. We anticipate that all patients will be enrolled 16 months
from when the trial opens. When the last patient is enrolled in the trial and all of the
metastatic biopsies have been collected, they will be shipped in bulk on dry ice to
laboratory for RNA(ribonucleic acid) isolation, RNA quality assessment and processing,
microarray hybridization, microarray data quality assessment, and "BRCAness" prostate cancer
signature application. Frozen biopsies will be processed for microarray analysis using laser
capture microdissection and RNA amplification using adaptations of previously published
methods. The application of the prostate cancer BRCAness signature will take place over two

Inclusion Criteria:

1. Patients must have histologically confirmed adenocarcinoma of the prostate.

2. Radiographic evidence of metastatic disease (Bone scan, CT(Computerized Tomography)
scan, or MRI(Magnetic Resonance Imaging) are acceptable) amenable to image-guided

3. Castrate levels of testosterone (testosterone <50 ng/dL) on androgen deprivation
therapy (ADT). LHRH(luteinizing hormone releasing hormone)agonist therapy must
continue while on study unless patient has previously undergone an orchiectomy.

4. The patient must have discontinued antiandrogens (bicalutamide, flutamide or
nilutamide) 30 days prior to baseline PSA.

5. Progression on at least one line of a prior docetaxel-based chemotherapy.

6. Patients must have adequate organ and marrow function as defined below:

- Absolute neutrophil count >1,500/μl

- Platelets >100,000/μl

- GFR(glomerular Filtration Rate) >30 ml/min

- ALT(Alanine transaminase) and AST(Aspartate transaminase) ≤ 2.5 X upper limit
of normal (ULN) or ≤ 5 X ULN in patients with liver metastasis

7. Age > 18 years

8. Ability to take oral medications (pills must be swallowed whole)

9. ECOG (Eastern Cooperative Oncology Group) performance status 0-2

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

11. Patients must be willing to undergo an image-guided biopsy of a metastatic site on at
least one occasion.

12. Patient agrees to utilize contraception while enrolled in the trial

Exclusion Criteria:

1. Patients who have received prior treatment with a platinum chemotherapy.

2. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection (requiring antifungal, antibiotic or antiviral therapy), history of
symptomatic congestive heart failure (NYHC (New York Heart Association
Classification) III), unstable angina pectoris, cardiac arrhythmia (uncontrolled
SVT(Super ventricular tachycardia)or any VT(ventricular tachycardia), or psychiatric
illness/social situations that would limit compliance with study requirements.

3. Patients with a medical contraindication to image-guided biopsies

4. Patients with a severe allergic reaction to satraplatin compounds.

5. Has a history of a prior malignancy with the exception of the following: adequately
treated basal cell or squamous cell skin cancer, or other cancers for which the
subject has been disease-free for at least 5 years.

6. Has had radiation therapy within 30 days prior to being registered for protocol

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the efficacy of Satraplatin as second line therapy in men with CRCP

Outcome Description:

Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level withtin 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

William K Oh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Metastatic
  • Castration Resistant
  • Prostate Cancer
  • Prostatic Neoplasms



Mount Sinai Medical Center New York, New York  10029