Pharmacogenetic study in castration-resistant prostate cancer patients treated with abiraterone acetate

Phase 1

• Conditions: Prostate cancer metastatic; MedDRA version: 14.1Level: 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: EUCTR2012-005036-28-FR
• Lead Sponsor: CENTRE ANTOINE LACASSAGNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-19
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 330

Inclusion Criteria

1.Age > 18 years.
2.Histologically confirmed prostate adenocarcinoma.
3.ECOG = 2.
4.Evidence of metastatic disease by the presence of documented locoregional or distant metastases on CT scan of the abdomen and/or pelvis, or bone scintigraphy.
5.Patients who have had disease progression during or after prior docetaxel chemotherapy regimen, defined as:
a.Progressive measurable disease : At least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed –or- the appearance of one or more new measurable lesions as assessed by CT scan. Soft tissue disease progression defined by modified RECIST 1.1 criteria (baseline lymph node size must be = 2.0 cm to be considered target or evaluable lesion).
OR
b.Bone Scan Progression: appearance of 2 or more new lesions on bone scan.
OR
c.Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 2.0 ng/mL is required for study entry.
NOTE: Androgen ablative therapy may have included either medical or surgical castration.
6.At least one prior chemotherapy regimen of docetaxel.
7.At least 28 days had to have elapsed between the withdrawal of antiandrogens and enrolment, except LH-RH agonist therapy that must be continued throughout this study for patients who were already treated by it.
8.Hormonal castration confirmed biologically (testosterone < 0.5 ng/ml).
9.Patient with adequate organ function

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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

1.Patients already treated with abiraterone acetate.
2.Known hypersensitivity or allergy to abiraterone or any of the excipients (see attachment 9).
3.Patients suffering from severe liver or renal impairment.
4.Any radiation within 28 days prior to study entry.
5.Patient with central nervous system (CNS) metastasis or with history of CNS metastasis.
6.Patient treated for a cancer other than prostate cancer, with the exception of basal cell carcinoma, within the past 5 years.
7.Treatment on another therapeutic clinical trial within 28 days before enrolment
8.Prior treatment with novel hormonal agents including enzalutamide, orteronel, ARN509, EPI100 and novel non hormonal treatments including cabozantinib, alpharadin.
9.Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
10.Permanent contraindication to corticosteroids.
11.Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol.
12.Patient enables to give informed consent.
13.People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code

Study & Design

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