Castration resistant prostate cancer docetaxel and androgen receptor-targeted agent (abiraterone or enzalutamide) naïve. MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: XTANDI
Product Name: XTANDI
Product Code: [L02BB04]
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: 00329400
CAS Number: 915087-33-1
Current Sponsor code: RADAR-1 CRPC
Other descri
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Male aged 18 years and above 3. Histologically or cytological confirmed adenocarcinoma of the prostate 4. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is the only evidence of metastasis, it must be = 2 cm in diameter. Alternatively, metastatic disease can be diagnosed by PET-Choline. 5. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria 6. At least one negative prognostic features between: I. Mildly symptomatic prostate cancer defined as per BPI Question #3 (worst pain in last 24 hours) value 2 or 3 or II. Asymptomatic prostate cancer defined as per BPI Question #3 (worst pain in last 24 hours) value 0 or 1 and at least one between • PSA=80 ng/dl • Gleason Score = 8 • PSA doubling time = 3 months • Time from start ADT to CRPC less =65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: 1. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 2. Pathological finding consistent with small cell carcinoma of the prostate greater than 10% 3. Known brain metastasis 4. Use of major opiate analgesics for cancer-related pain (codeine and tramadol are allowed) 5. Prior cytotoxic chemotherapy, Androgen Receptor-targeted agent or biologic therapy for the treatment of CRPC or CSPC (previous bicalutamide is allowed) 6. Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1 7. Radiation or radionuclide therapy for treatment of metastatic CRPC and CSPC 8. Bicalutamide, nilutamide within 6 weeks of Cycle 1 Day 1 9. Uncontrolled hypertension (systolic BP = 160 mmHg or diastolic BP = 95 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 10. Active or symptomatic viral hepatitis or chronic liver disease 11. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline 12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy 13. Other malignancy with a previous diagnosis within 5 years (with the exclusions of NMIBC, CIN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if docetaxel is superior to Androgen Receptor-targeted agent (abiraterone or enzalutamide) for treatment of patients with mCRPC and negative prognostic factors in terms of PFS.;Secondary Objective: To investigate if docetaxel is superior to Androgen Receptor-targeted agent (abiraterone or enzalutamide) for treatment of patients with mCRPC and negative prognostic factors in terms of biochemical response, radiographic progression, overall survival and quality of life.;Primary end point(s): To compare the radiographic Progression-Free Survival (rPFS) rate at 9 months of chemotherapy (Arm A, docetaxel plus prednisone) versus androgen receptor targeted therapy (Arm B, enzalutamide or abiraterone acetate plus prednisone) in mCRPC patients with adverse prognostic factors.;Timepoint(s) of evaluation of this end point: nine months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone in terms of PSA response; To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone in terms of radiographic progression-free survival (rPFS); To compare efficacy of docetaxel plus prednisone to enzalutamide or abiraterone acetate plus prednisone in terms of overall survival (OS).;Timepoint(s) of evaluation of this end point: nine months; 18 months; 18 months | — |
Countries
Italy
Contacts
Public ContactDirezione Scientifica Fondazione Po
Direzione scientifica Fondazione Policlinico A.Gemelli IRCCS
Outcome results
None listed