Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Satraplatin
Intervention description: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Intervention MeSH terms: Satraplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic; Castration Resistant; Prostate Cancer

Summary:

      The purpose of the study is to test genes for BRCAness(BRCA[BReast CAncer] gene) Studying
      these genes could help predict which patients would benefit from treatment with satraplatin,
      a medication being used for subjects who have failed prior chemotherapy. All subjects will
      have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene
      signature may be able to predict response to satraplatin and a tool will be developed to be
      able to screen patients likely to benefit from satraplatin. Subjects will all receive
      Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be
      evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered
      responders if they have measurable disease meeting criteria for partial or complete response.
      PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.
    

Eligibility criteria:

        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
             biopsy.

          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
             therapy.