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

NCT ID: NCT03101046

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2021-12-31

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 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.

Conditions

Prostate Carcinoma; Castration-resistant Prostate Cancer; Circulating Tumor Cells; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Cabazitaxel

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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)

Group Type: OTHER

Docetaxel

Intervention Type: DRUG

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).

Interventions

Cabazitaxel

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

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

JEVTANA

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: collaborator

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane CULINE

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Louis Paris

Locations

ICO-Site Paul Papin

Angers, , France

CHD Vendée

La Roche-sur-Yon, , France

Centre Léon Berard

Lyon, , France

Stéphane CULINE

Paris, , France

ICO-Site René Gauducheau

Saint-Herblain, , France

Countries

France

Other Identifiers

2016-002429-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GETUG-AFU-28 - UC-0160/1613

Identifier Type: -

Identifier Source: org_study_id