Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic (TACTIK)

February 9, 2022 updated by: UNICANCER

Personalized Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic During Chemotherapy: A GETUG-AFU 28 Study

This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCRPC defined as ≥5 circulating tumor cells (CTCs) / 7.5 mL after 2 cycles of docetaxel.

Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients with ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.

A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and <5 CTCs / 7.5 mL after 2 cycles of docetaxel) will receive 6 additional cycles of docetaxel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49055 cedex 02
        • ICO-Site Paul Papin
      • La Roche-sur-Yon, France, 85925 cedex 9
        • CHD Vendee
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Paris, France, 75475
        • Stéphane CULINE
      • Saint-Herblain, France, 44805
        • ICO-Site René Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Written informed consent signed prior any study-related procedures
  2. Adult men ≥18 years
  3. Histologically confirmed prostate adenocarcinoma
  4. Metastatic disease as evidenced by imaging (bone scan, CT-scan, MRI and/or PET-choline).
  5. Documented progressive disease while receiving continuous hormonal treatment with luteinizing hormone-releasing hormone (LH-RH) agonist or antagonist or after surgical castration (at least one visceral or soft tissue metastatic lesion, including a new lesion). Patient with non-measurable disease must have documented rising prostate-specific antigen (PSA) levels or appearance of new lesion
  6. Effective castration assessed by testosterone levels ≤50 ng/dL
  7. Patients with a Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  8. Patients affiliated to social security scheme

Exclusion Criteria:

  1. Prior chemotherapy for metastatic prostate cancer except estramustine <1 year from the end of adjuvant and/or neoadjuvant chemotherapy for localized disease <1 year from the end of chemotherapy for de novo metastatic prostate cancer
  2. Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to >30% of bone marrow
  3. Less than 1 month elapsed from prior treatment with radiotherapy, surgery and less than 2 weeks from any previous hormonal treatment except for LH-RH agonists/antagonists (which are to be continued). Patients may be treated with bisphosphonates prior to study entry which should be pursued,
  4. History of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis or new evidence of brain or leptomeningeal disease
  5. Patient with any of the following abnormal laboratory tests: hemoglobin <10 g/dL, absolute neutrophil count <1.5 x 10⁹/L, platelets <100 x 10⁹/L, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN), total bilirubin >1.0 ULN, creatinine clearance <40 ml/mn (MDRD)
  6. History of hypersensitivity to polysorbate 80 or docetaxel
  7. Contraindication to the use of corticosteroids
  8. Peripheral neuropathy grade ≥2 according to NCI CTCAE v4.0
  9. Ventricular ejection fraction <50% (echography or scintigraphy)
  10. Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack
  11. Any of the following within 3 months prior to study entry: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event
  12. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  13. Planned vaccination with a live or live-attenuated vaccines
  14. Participation in another clinical trial and any treatment with any investigational drug within 30 days prior to randomization
  15. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
  16. Patients with reproductive potential who do not agree to use effective method of contraception during the treatment
  17. Person deprived of their liberty or under protective custody or guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Group1: Arm A (standard arm) + Arm B (experimental arm)

Arm A: Patients with docetaxel resistant mCRPC (defined as having ≥5 CTCs / 7.5 mL) will receive up to 8 additional cycles of docetaxel (75 mg/m² every 3 weeks) after randomization.

Arm B: Patients with docetaxel resistant mCRPC (defined as having ≥5 CTCs / 7.5 mL) will receive up to 10 cycles of cabazitaxel (20 mg/m² every 3 weeks) after randomization.
Drug: Cabazitaxel
Experimental treatment arm: patients will be treated with intravenous cabazitaxel 20 mg/m² every 3 weeks up to 10 cycles.
Other Names:
  • JEVTANA
Drug: Docetaxel
standard treatment arm and cohort: Docetaxel is administered at the dose of 75 mg/m² over 1 hour every 3 weeks for 6 cycles (D1=D22).
OTHER: Group 2: Cohort
Patients with docetaxel sensitive mCRPC (defined as having <5 CTCs / 7.5 mL) will receive up to 8 additional cycles of docetaxel (75 mg/m² every 3 weeks)
Drug: Docetaxel
standard treatment arm and cohort: Docetaxel is administered at the dose of 75 mg/m² over 1 hour every 3 weeks for 6 cycles (D1=D22).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biological activity of chemotherapy
Time Frame: 18 weeks after randomisation
Biological activity of chemotherapy as defined as < 5 CTCs per 7.5 ml at the end of chemotherapy with docetaxel or cabazitaxel.
18 weeks after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNICANCER

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Bergonié
National Cancer Institute, France
Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stéphane CULINE, Hôpital Saint Louis Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GETUG-AFU-28 - UC-0160/1613
  • 2016-002429-12 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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