Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID: NCT01289067
Run by: William K. Oh
People needed: 13
Starts: 2010-12-01
Expected to finish: 2013-05-01
Last updated by the study team: 2018-02-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed adenocarcinoma of the prostate.
Radiographic evidence of metastatic disease (Bone scan, CT(Computerized Tomography) scan, or MRI(Magnetic Resonance Imaging) are acceptable) amenable to image-guided biopsy.
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.
The patient must have discontinued antiandrogens (bicalutamide, flutamide or nilutamide) 30 days prior to baseline PSA.
Progression on at least one line of a prior docetaxel-based chemotherapy.
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
Age > 18 years
Ability to take oral medications (pills must be swallowed whole)
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Ability to understand and the willingness to sign a written informed consent document
Patients must be willing to undergo an image-guided biopsy of a metastatic site on at least one occasion.
Patient agrees to utilize contraception while enrolled in the trial

You may not qualify if…

Patients who have received prior treatment with a platinum chemotherapy.
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.
Patients with a medical contraindication to image-guided biopsies
Patients with a severe allergic reaction to satraplatin compounds.
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.
Has had radiation therapy within 30 days prior to being registered for protocol therapy.

Where it is running

Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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