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Phase 2 of Carbo, Taxel and Abi in Metastatic Castration Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03934840
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression‐free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Cabazitaxel Drug: Carboplatin Drug: Abiraterone Drug: Prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in Metastatic Castration Sensitive Prostate Cancer With and Without DNA Repair Mutations
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Carboplatin, Cabazitaxel and Abiraterone Drug: Cabazitaxel
20 mg/m2 Q 21 days

Drug: Carboplatin
AUC 4 Q21 Days x 6 cycles with ADT

Drug: Abiraterone
1000 mg PO daily

Drug: Prednisone
5 mg PO daily on chemotherapy completion




Primary Outcome Measures :
  1. Prostate-Specific Antigen (PSA) or Radiographic Progression [ Time Frame: 1 Year ]
    Proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria


Secondary Outcome Measures :
  1. Progression‐Free Survival (PFS) [ Time Frame: 1 Year ]
    Incidence of PFS

  2. PSA Nadir [ Time Frame: 1 Year ]
    Time to time to PSA nadir

  3. Incidence of adverse events [ Time Frame: 1 Year ]
    Safety and Tolerability

  4. Incidence of Homologous Recombination Deficiency (HRD) [ Time Frame: 1 Year ]
    Incidence of HRD

  5. PSA Complete Response Rate [ Time Frame: 1 Year ]
    PSA complete response rate (PSA <0.2 ng/ml) in patient with mutations in DNA repair genes

  6. PSA Complete Response Rate [ Time Frame: 1 Year ]
    PSA complete response rate (PSA <0.2 ng/ml) in patient without mutations in DNA repair genes

  7. PSA Progression [ Time Frame: 1 Year ]
    Time to PSA progression



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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:

  • Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
  • Histologically confirmed prostate cancer.
  • High volume metastatic disease (defined as the presence of visceral metastases or ≥3 bone lesions).
  • ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed (i.e. ADT used previously in courses of radiation).
  • Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if they have not undergone orchiectomy.
  • ECOG Performance Status 0 or 1 (see Appendix A)
  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:

    • Absolute neutrophil count ≥ 1.5 × 109

      /L.

    • Platelets ≥ 100 × 109

      /L.

    • Hemoglobin ≥ 9 g/dl.
    • Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min
    • In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. If the patient has liver metastases, ALT and AST <5 x ULN
    • Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well‐documented Gilbert's Syndrome.
  • Sexually active males must use a condom during intercourse while taking study drugs and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Fertile males must use a condom with spermicide (double barrier method).
  • Age ≥ 18 years

Exclusion Criteria:

  • Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
  • Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks
  • Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days of the date of the first dose.
  • Other systemic therapies for prostate cancer within 28 days or 5 half‐lives, whichever is shorter, prior to day 1 of chemotherapy (with the exception of anti‐androgens like bicalutamide).
  • PSA <2.0 ng/mL at diagnosis.
  • If present, peripheral neuropathy must be ≤ Grade 1
  • Patients with an active second malignancy that could, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial.
  • Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:

    • At least 4 weeks from prior therapy completion (including radiation and/or surgery) prior to starting the study treatment
    • Clinically stable CNS tumor at the time of screening.
    • Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement
  • Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of treating investigator.
  • Patient has a history of non‐compliance to medical regimen or inability to grant consent.

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): NCT03934840


Contacts
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Contact: Charles Ryan, MD 6126249487 ryanc@umn.edu

Locations
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United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Tim Krepski    612-273-2800    tkrepsk1@fairview.org   
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: Charles Ryan, MD University of Minnesota, Division of Hematology, Oncology and Transplantation

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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03934840     History of Changes
Other Study ID Numbers: 2018LS158
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Carboplatin
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal