A RAndomized, open label, multicenter study of Docetaxel versus an Androgen Receptor-targeted agent (abiraterone or enzalutamide) as first-line of therapy in mCRPC patients with adverse prognostic factors (RADAR-1 CRPC)
- Conditions
- Castration resistant prostate cancer docetaxel and androgen receptor-targeted agent (abiraterone or enzalutamide) naïve.MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003761-17-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 200
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 < 1 year
7.Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM).
8.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2
9.Adequate bone marrow and chemistry values defined as:
a.Hemoglobin = 10.0 g/dL independent of transfusion
b.Platelet count =100,000/µL
c.Serum albumin = 3.5 g/dL
d.Serum creatinine < 1.5 x ULN or a calculated creatinine clearance = 60 mL/min
e.Serum potassium = 3.5 mmol/L
f.Liver function:
•Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert’s disease)
•AST or ALT < 2.5 x ULN
10.Able to swallow the study drug whole as a tablet
11.Life expectancy of at least 6 months
12.Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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