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Phase 1

• Conditions: metastatic hormone-naïve prostate cancer; MedDRA version: 27.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000142-35-IE
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 1168

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the
prostate,
2. Metastatic disease documented by a positive bone scan (any technique) and CTscan or MRI. For patients with nodal metastases only,
only patients with extra-pelvic enlarged lymph nodes (pelvic lymph
nodes located below the iliac bifurcation) can be included if they have
either:
o At least one extra-pelvic lymph node = 2 cm
or
o extra-pelvic lymph node (s) = 1 cm if the patients also have at least
one pelvic lymph node = 2 cm
3. Patients with ECOG = 1 (patient with PS 2 due to bone pain can be
accrued in the trial),
4. Life expectancy of at least 6 months,
5. Male aged = 18 years old, and =80 years old
6. Hematology values:
• Hemoglobin = 10.0 g/dL,
• Platelet count = 100,000/mL,
• Neutrophil = 1500 cells/mm3
7. Biochemistry values:
• Renal function: Serum creatinine < 1.5 x ULN or a calculated
creatinine clearance = 60 mL/min,
• Serum potassium = 4 mmol/L,
• Liver function:
- Serum bilirubin = 1.5 x ULN (except for patients with documented
Gilbert's disease),
- AST and ALT = 1.5 x ULN (and = 5 ULN in case of liver metastases),
• ALK-P = 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if
bilirubin is normal)
8. Patients must have received ADT for a maximum of 3 months before
randomization and there must be a delay of minimum 6 weeks between
the start of ADT and the start of Docetaxel,
9. Patients willing to receive Docetaxel,
10. Patients might have received previous radiation therapy directed to
bone lesions,
11. Patients able to take oral medication,
12. Patients who have received the information sheet and signed the
informed consent form,
13. Male patients who will receive Docetaxel and/or Abiraterone acetate
and have partners of childbearing potential and/or pregnant partners
must use a method of birth control in addition to an adequate barrier
protection (condoms) as determined to be acceptable by the study
doctor during the treatment period and for 4 weeks after the last dose of
abiraterone acetate and/or for 6 months after the last dose of Docetaxel,
14. Patients must be willing and able to comply with scheduled visits,
treatment plan, laboratory tests and other study procedures,
15. Patients with a public or a private health insurance coverage,
according to local laws for participation in clinical trials.
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 584
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 584

Exclusion Criteria

1. Patients with previous definitive local treatment directed to the
prostate primary cancer (radiotherapy, brachytherapy, radical
prostatectomy, ultrasound, cryotherapy, or other). A previous transurethral
resection of the prostate (TURP) and previous local treatments
of metastase are allowed,
2. Prior cytotoxic chemotherapy or biological therapy for the treatment
of CRPC,
3. Any chronic medical condition requiring a higher dose of
corticosteroid than 5mg prednisone/prednisolone twice daily,
4. Active infection or other medical condition for which
prednisone/prednisolone (corticosteroid) use would be contraindicated,
5. Previously treated with ketoconazole for prostate cancer for more
than 7 days,
6. Prior systemic treatment with an azole drug (e.g. fluconazole,
itraconazole) within 4 weeks of randomization,
7. Hypertension not controlled by an anti-hypertensive treatment not
modified for more than 3 months (systolic BP = 160 mmHg or diastolic
BP = 95 mmHg; 3 consecutive measures taken 5 minutes apart),
8. Severe or moderate hepatic impairment (Child – Pugh class C or B)
9. Active or symptomatic viral hepatitis or chronic liver disease (except
Gilbert's disease),
10. History of pituitary or adrenal dysfunction,
11. Clinically known significant heart disease in the past 6 months as evidenced by myocardialinfarction, or arterial thrombotic events , 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. Patient with unstable pulmonary disease (eg. Pulmonary embolism)
14. Pathological finding consistent with small cell carcinoma of the
prostate,
15. History of malignancy, except non-melanoma skin cancer, with a =
30% probability of recurrence within 24 months,
16. Known allergies, hypersensitivity or intolerance to the study drugs or
excipients,or docetaxel,
17. Administration of an investigational therapeutic within 30 days of
randomization,
18. Patients already included in another therapeutic trial involving an
experimental drug, (patient in a non-experimental trial with no
modification of the patient's care can be included),
19. Patients with significantly altered mental status prohibiting the
understanding of the study or with psychological, familial, sociological or
geographical condition potentially hampering compliance with the study
protocol and follow-up schedule or any condition which, in the opinion of
the investigator, would preclude participation in this trial. Those
conditions should be discussed with the patient before registration in the
trial,
20. Individual deprived of liberty or placed under the authority of a
tutor.
21. Patients with impaired vision should undergo a prompt and complete
ophtalmologic examination. Patients with Cystoid Macular Oeadema
cannot be included due to a potential risk of deterioration associated
with docetaxel.
22. Concomitant use of strong CYP3A4 inhibitors ( clarithromyin,
indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified