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

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ClinicalTrials.gov Identifier: NCT01289067
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Prostate Cancer Foundation
Information provided by (Responsible Party):
William K. Oh, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 7, 2011
First Posted Date  ICMJE February 3, 2011
Results First Submitted Date  ICMJE January 10, 2017
Results First Posted Date  ICMJE February 13, 2018
Last Update Posted Date February 13, 2018
Study Start Date  ICMJE December 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
Efficacy of Satraplatin as Second Line Therapy in Men With CRCP [ Time Frame: 3 months ]
Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2011)
To determine the efficacy of Satraplatin as second line therapy in men with CRCP [ Time Frame: 3 months ]
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.
Change History Complete list of historical versions of study NCT01289067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2018)
  • Number of Days to Maximum Decline in PSA [ Time Frame: baseline and 3 months ]
    Response rate - Maximum decline in PSA that occurs during treatment.
  • Progression Free Survival (PFS) [ Time Frame: up to 2 years ]
    Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression.
  • Overall Survival [ Time Frame: 24 months ]
    Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2011)
  • To assess response rates [ Time Frame: 3 months ]
    Response will be evaluated in this study using PSA (Prostate-Specific Antigen) measurements (every 4 weeks) and by using the Response Evaluation Criteria in Solid Tumors(RECIST) every 2 cycles (or approximately every 9 weeks). PSA response will be measured as the percentage of change in PSA from baseline to 12 weeks in therapy (or earlier if patients discontinue therapy prior to 12 weeks) as well as the maximum decline in PSA that occurs at any point during treatment. PSA decline will be reported globally using a waterfall plot.
  • Progression Free Survival (PFS) [ Time Frame: 3 months ]
    Progression Free Survival is measured from the time of the initiation of therapy until the first dat that recurrent or progressive disease is objectively documentsd. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death.
  • Overall Survival [ Time Frame: 24 months ]
    Patients will be followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca
Official Title  ICMJE 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
Brief 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.
Detailed Description

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 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: Satraplatin
Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Other Name: JM-118
Study Arms  ICMJE Satraplatin, Single Arm
Intervention: Drug: Satraplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2011)
30
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01289067
Other Study ID Numbers  ICMJE GCO 10-1222
Prostate Cancer Foundation ( Other Identifier: Prostate Cancer Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William K. Oh, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE William K. Oh
Collaborators  ICMJE Prostate Cancer Foundation
Investigators  ICMJE
Principal Investigator: William K Oh, M.D. Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP