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Prostate CarcinomaPhase 2TACTIKNCT03101046

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

A Phase 2 study testing Cabazitaxel and Docetaxel in people with Prostate Carcinoma and Castration-resistant Prostate Cancer, run by UNICANCER at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 mCRPC defined as ≥5 circulating tumor cells (CTCs) / 7.5 mL after 2 cycles of docetaxel. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Cabazitaxel and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesFrance
Study dates
15 Nov 2018to 31 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent signed prior any study-related procedures
  • Adult men ≥18 years
  • Histologically confirmed prostate adenocarcinoma
  • Metastatic disease as evidenced by imaging (bone scan, CT-scan, MRI and/or PET-choline).
  • 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
  • Effective castration assessed by testosterone levels ≤50 ng/dL
  • Patients with a Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Patients affiliated to social security scheme

Who cannot join

  • 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
  • Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to >30% of bone marrow
  • 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,
  • History of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis or new evidence of brain or leptomeningeal disease
  • 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)
  • History of hypersensitivity to polysorbate 80 or docetaxel
Show all 17Show fewer
  • Contraindication to the use of corticosteroids
  • Peripheral neuropathy grade ≥2 according to NCI CTCAE v4.0
  • Ventricular ejection fraction <50% (echography or scintigraphy)
  • 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
  • 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
  • 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
  • Planned vaccination with a live or live-attenuated vaccines
  • Participation in another clinical trial and any treatment with any investigational drug within 30 days prior to randomization
  • Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
  • Patients with reproductive potential who do not agree to use effective method of contraception during the treatment
  • Person deprived of their liberty or under protective custody or guardianship

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • ICO-Site Paul Papin

    Angers, 49055 cedex 02

  • CHD Vendée

    La Roche-sur-Yon, 85925 Cedex 9

  • Centre Léon Berard

    Lyon, 69008

  • Stéphane CULINE

    Paris, 75475

  • ICO-Site René Gauducheau

    Saint-Herblain, 44805

Other trials in France

About this study

Official title: 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.

Being tested
Cabazitaxel, Docetaxel
Keywords
Docetaxel, Cabazitaxel
Medical subject headings
Prostatic Neoplasms, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabazitaxelDrug

    Also called JEVTANA

    Experimental treatment arm: patients will be treated with intravenous cabazitaxel 20 mg/m² every 3 weeks up to 10 cycles.

  • DocetaxelDrug

    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).

Study groups in NCT03101046
Study groupRoleWhat they receive
Group1: Arm A (standard arm) + Arm B (experimental arm)OtherArm 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.
Receives: Drug: Cabazitaxel; Drug: Docetaxel
Group 2: CohortOtherPatients 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)
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biological activity of chemotherapy

    Biological activity of chemotherapy as defined as < 5 CTCs per 7.5 ml at the end of chemotherapy with docetaxel or cabazitaxel.

    Measured: 18 weeks after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start15 Nov 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03101046
Sponsor's protocol ID
GETUG-AFU-28 - UC-0160/1613
Other IDs
2016-002429-12, 2016
Acronym
TACTIK
Status last verified
Feb 2022
First submitted
22 Mar 2017
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel and Docetaxel in people with Prostate Carcinoma and Castration-resistant Prostate Cancer, run by UNICANCER at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biological activity of chemotherapy (time frame: 18 weeks after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03101046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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