Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03101046
Recruitment Status : Suspended (Temporary suspension since March 2020 due to COVID-19 pandemic)
First Posted : April 4, 2017
Last Update Posted : May 4, 2020
Sponsor:
Collaborators:
National Cancer Institute, France
Institut du Cancer de Montpellier - Val d'Aurelle
Institut Bergonié
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

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 mCPRC defined as ≥5CTCs / 7.5mL after 2 cycles of docetaxel.

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


Condition or disease Intervention/treatment Phase
Prostate Carcinoma Castration-resistant Prostate Cancer Circulating Tumor Cells Chemotherapy Drug: Cabazitaxel Drug: Docetaxel Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic During Chemotherapy: A GETUG-AFU 28 Study
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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 Name: 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).

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).




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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 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 PSA levels or appearance of new lesion
  6. Effective castration assessed by testosterone levels ≤50 ng/dL
  7. Patients with a performance status ECOG ≤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, AST/SGOT and/or ALT/SGPT >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, 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

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): NCT03101046


Locations
Layout table for location information
France
Stéphane CULINE
Paris, France, 75475
Sponsors and Collaborators
UNICANCER
National Cancer Institute, France
Institut du Cancer de Montpellier - Val d'Aurelle
Institut Bergonié
Investigators
Layout table for investigator information
Principal Investigator: Stéphane CULINE Hôpital Saint Louis Paris
Layout table for additonal information
Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03101046    
Other Study ID Numbers: GETUG-AFU-28 - UC-0160/1613
2016-002429-12 ( EudraCT Number )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by UNICANCER:
Docetaxel
Cabazitaxel
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action