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Carboplatin in Castration-resistant Prostate Cancer (PRO-PLAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311764
Recruitment Status : Terminated
First Posted : December 8, 2014
Last Update Posted : January 23, 2020
Sponsor:
Collaborators:
Teva Pharma
University Hospital, Zürich
Information provided by (Responsible Party):
Aurelius Omlin, Cantonal Hospital of St. Gallen

Study Description
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Brief Summary:
Open label, non-randomised phase II clinical pilot study

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Drug: Carboplatin Phase 2

Detailed Description:
Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Arm Open Label Phase II Pilot Study of Carboplatin in Patients With Metastatic Castrationresistant Prostate Cancer (CRPC) and PTEN Loss and/or DNA Repair Defects
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carboplatin
Carboplatin will be administered weekly
 Drug: Carboplatin
Carboplatin will be administered weekly


Outcome Measures
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Primary Outcome Measures :
  1. Response [ Time Frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months ]
    Soft tissue or PSA Response


Secondary Outcome Measures :
  1. Rate of PSA declines of ≥30% [ Time Frame: Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months) ]
    PSA

  2. OS [ Time Frame: Time Frame: livelong follow-up ]
    Overall survival (OS) form start of Carboplatin

  3. rPFS [ Time Frame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months ]
    Radiological progression-free survival (rPFS) from start of carboplatin

  4. PSA [ Time Frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months ]
    Time to PSA progression

  5. Safety as per CTC AEv4.03 [ Time Frame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months ]
    Number of patients with adverse events

  6. Disease control rate [ Time Frame: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months ]
    Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria

  7. PTEN loss [ Time Frame: Pre-study biopsy sample ]
    Evaluation of PTEN loss by FISH (Frequency and correlation with IHC)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written Informed Consent
  2. Adult patients with histological diagnosis of adenocarcinoma of the prostate.
  3. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  4. Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
  5. DNA repair defects as per central assessment
  6. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2

  7. Progression of disease by any of the criteria listed here:

    • PSA utilizing PCWG 2 criteria
    • Bone scan
    • RECIST 1.1

  8. Adequate organ and bone marrow function as evidenced by:

    • Haemoglobin ≥8.0 g/dL
    • Absolute neutrophil count ≥1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • AST and/or ALT < 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT <5 x ULN
    • Total bilirubin < 2.0 x ULN (except for patients with Gilbert's disease)
    • Creatinine Clearance ≥30ml/min
  9. Patient must agree in the biomarker studies including the fresh tumour biopsies

Exclusion Criteria:

  1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
  2. Prior treatment with any prior platinum based chemotherapy,
  3. Major surgery within 4 weeks prior to planned start of treatment
  4. Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
  5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  6. Previous enrolment into the current study
  7. Active secondary malignancy that requires systemic therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311764


Locations
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Switzerland
Cantonal Hospital Chur
Chur, Graubuenden, Switzerland, 7000
Luzern Cantonal Hospital
Luzern, Switzerland
Cantonal Hospital St.Gallen
St.Gallen, Switzerland, 9007
Sponsors and Collaborators
Aurelius Omlin
Teva Pharma
University Hospital, Zürich
Investigators
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Principal Investigator: Aurelius G Omlin, MD Cantonal Hospital St. Gallen
More Information
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Responsible Party: Aurelius Omlin, MD, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02311764    
Other Study ID Numbers: CTU-14005
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Carboplatin
Antineoplastic Agents