Clinical Trials /

Carboplatin in Castration-resistant Prostate Cancer

NCT02311764

Description:

Open label, non-randomised phase II clinical pilot study

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Carboplatin in Castration-resistant Prostate Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CTU-14005
  • NCT ID: NCT02311764

Conditions

  • Prostatic Neoplasm

Interventions

DrugSynonymsArms
CarboplatinCarboplatin

Purpose

Open label, non-randomised phase II clinical pilot study

Detailed Description

      Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant
      Prostate Cancer (CRPC) and DNA repair defects
    

Trial Arms

NameTypeDescriptionInterventions
CarboplatinExperimentalCarboplatin will be administered weekly
  • Carboplatin

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response
Time Frame:Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety Issue:
Description:Soft tissue or PSA Response

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:PSA
Measure:OS
Time Frame:Time Frame: livelong follow-up
Safety Issue:
Description:Overall survival (OS) form start of Carboplatin
Measure:rPFS
Time Frame:Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety Issue:
Description:Radiological progression-free survival (rPFS) from start of carboplatin
Measure:PSA
Time Frame:on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety Issue:
Description:Time to PSA progression
Measure:Safety as per CTC AEv4.03
Time Frame:on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety Issue:
Description:Number of patients with adverse events
Measure:Disease control rate
Time Frame:On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
Safety Issue:
Description:Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria
Measure:PTEN loss
Time Frame:Pre-study biopsy sample
Safety Issue:
Description:Evaluation of PTEN loss by FISH (Frequency and correlation with IHC)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aurelius Omlin

Last Updated

January 23, 2018