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Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.

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ClinicalTrials.gov Identifier: NCT04139772
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief Summary:
This is a randomized phase 3 trial aiming to compare the efficacy of docetaxel and hormone therapy as second line treatment in patients with mCRPC progressing after therapy with abiraterone or enzalutamide.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistent Prostate Cancer Drug: Docetaxel Drug: Abiraterone Acetate or Enzalutamide Phase 3

Detailed Description:

Patients will be randomized 1:1 to receive docetaxel or hormone therapy (abiraterone or enzalutamide based on previous treatment).

Docetaxel (standard) will be administered for 10 cycles (maximum).

Hormone therapy (experimental) will be administered until progression or unacceptable toxicity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Comparative Randomized Phase 3 Design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase III Trial Comparing Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamide.
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Docetaxel
Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.
Drug: Docetaxel
Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.

Experimental: Abiraterone or Enzalutamide

Patient will receive Abiraterone or Enzalutamide based on previous treatment.

Abiraterone given orally at the dose of 1000 mg daily plus oral prednisone 5 mg twice daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.

Enzalutamide given orally at the dose of 160 mg daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.

Drug: Abiraterone Acetate or Enzalutamide

Patient will receive Abiraterone or Enzalutamide based on previous treatment.

Abiraterone given orally at the dose of 1000 mg daily plus oral prednisone 5 mg twice daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.

Enzalutamide given orally at the dose of 160 mg daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.





Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: up to 5 years ]
    OS is defined as the time from randomization until death


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: up to 5 years ]
    PFS is defined as the time elapsed from the date of randomization to the date of progression, as defined by investigators, or the date of death, whichever comes first.

  2. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: up to 5 years ]
    as determined by investigator

  3. Incidence of symptomatic skeletal events (SSE) [ Time Frame: up to 5 years ]
    reporting the incidence and types of skeletal related events

  4. Time to symptomatic skeletal event (SSE) [ Time Frame: up to 5 years ]
    Time from the date of randomization to the date of documented symptomatic skeletal event

  5. Time to Pain Progression [ Time Frame: up to 5 years ]
    Time from the date of randomization to the date of pain progression

  6. Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0 [ Time Frame: baseline, during treatment (every 4 weeks) up to 5 years ]
    graded according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

  7. Determination of changes in quality of life [ Time Frame: baseline, during treatment up to 5 years ]
    EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis

  8. Radiographic response (bone lesions) [ Time Frame: up to 5 years ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  9. Radiographic response (soft tissue lesions) [ Time Frame: up to 5 years ]
    Prostate Cancer Working Group 3 (PCWG3) criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients with metastatic castration resistent prostate cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Distant metastatic disease
  • Previous first line treatment with abiraterone or enzalutamide for 6 cycles interrupted at least 2 weeks before randomization
  • Patients must be ≥ 18 years of age
  • Patients must have castrate serum level of testosterone of < 0.5 ng/mL ( 1.7 nmol/L)
  • Asymptomatic or Oligosymptomatic disease
  • Progressive disease according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria
  • ECOG performance status (PS) of 0-2
  • Sexually active males must use an accepted and effective method birth control measure
  • Written informed consent

Exclusion Criteria:

  • Prior exposure to docetaxel or abiraterone for treatment of hormone-sensitive metastatic prostate cancer (mHSPC)
  • History of adrenal insufficiency or hypoaldosteronism
  • Any medical condition that would make prednisone use contraindicated
  • Any medical condition that would make docetaxel use contraindicated
  • Patients unable to swallow orally administered medication
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) requiring antiretroviral therapy
  • Other malignancy within the last 5 years, except for adequately treated non melanoma skin cancer, bladder cancer (pTis, pTa, pT1) or other solid tumours curatively treated with no evidence of disease for > 5 years
  • Participation in another clinical study with an investigational product within 30 days prior to randomization
  • Persistent toxicities [>Common Terminology Criteria for Adverse Event (CTCAE) grade 1)] caused by previous cancer therapy prior to randomization
  • Uncontrolled medical conditions including diabetes mellitus. Clinically significant cardiovascular disease (e.g.: uncontrolled hypertension or arrhythmia, unstable angina pectoris, congestive heart failure (CHF), vascular disease (arterial thrombosis) and myocardial infarction within < 6 months
  • Left ventricular ejection fraction < 50%
  • Peripheral neuropathy [> CTCAE grade 2]
  • Inadequate bone marrow function defined as:

    • haemoglobin < 9.0 g/dL
    • absolute neutrophils count (ANC) <1.5 x 109/L (> 1500 per mm3)
    • platelet count <100 x 109/L (>100,000 per mm3)
  • Inadequate renal and hepatic function, defined as:

    • total serum bilirubin > 1,0 x ULN
    • AST/SGOT o ALT/SGPT > 1,5 x ULN
    • calculated creatinine clearance < 40 mL/min
    • potassium level < 3,5 mmol/L
    • Child-Pugh class C

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): NCT04139772


Contacts
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Contact: Sandro Pignata, MD, PhD +39 081 590 3637 s.pignata@istitutotumori.na.it
Contact: Clorinda Schettino, MD +39 081 590 1791 c.schettino@istitutotumori.na.it

Locations
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Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico Recruiting
Napoli, Italy, 80131
Contact: Sandro Pignata, MD, PhD    +39 081 590 3637    s.pignata@istitutotumori.na.it   
Contact: Clorinda Schettino, MD    +39 081 590 1791    c.schettino@istitutotumori.na.it   
Principal Investigator: Sandro Pignata, MD, PhD         
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Sandro Pignata, MD, PhD National Cancer Institute, Naples
Principal Investigator: Gaetano Facchini, MD National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, MD, PhD National Cancer Institute, Naples
Principal Investigator: Orazio Caffo, MD Oncology Department, Ospedale Santa Chiara, Trento
Study Chair: Clorinda Schettino, MD National Cancer Institute, Naples
Additional Information:
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT04139772    
Other Study ID Numbers: Meet-Uro4
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute, Naples:
metastatic castration-resistent prostate cancer
asymptomatic or oligosymptomatic
hormone therapy
docetaxel
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Docetaxel
Abiraterone Acetate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors