The study compares the therapy of abiraterone acetate plus LHRH-therapy with the therapy of abiraterone acetate allone in patients with recurrent prostate cancer in spite of chemotherapy and castration, the therapy for every single patient gets select by chance

• Conditions: Medically castrated male patients with chemotherapy-naïve, castration-resistant, metastatic CRPC who have shown tumor progression and are non- or mildly-symptomatic; MedDRA version: 16.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005717-39-DE
• Lead Sponsor: niversität des Saarlandes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-23
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Written Data Protection Consent has been obtained
3. Male aged 18 years and above
4. Histologically or cytologically confirmed adenocarcinoma of the prostate
5. 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
6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 for the question of worst pain within last 24 hours (Appendix 8) will be considered
asymptomatic, and a score of 2-3 will be considered mildly symptomatic.
8. Medically castrated, with testosterone levels of <20-50 ng/dl (< 2.0 nM).
9. Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (=4 weeks since last flutamide, =6 weeks since last bicalutamide or nilutamide).
10. Eastern Cooperative Oncology Group (ECOG) Performance Status of =2
11. Hemoglobin =9.0 g/dL independent of transfusion
12. Platelet count =100,000 /µl
13. Serum albumin =3.0 g/dl
14. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance =60 ml/min
15. Serum potassium =3.5 mmol/l
16. Liver function:
a. Serum bilirubin <1.5 x ULN (except for patients with documented Gilbert’s disease)
b. AST or ALT <2.5 x ULN
17. Able to swallow the study drug whole as a tablet
18. Life expectancy of at least 6 months
19. 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 1 week 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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Surgical castration (i.e. orchiectomy).
2. Application of any LHRH-therapy (LHRH-analogue or LHRH-antagonist) within 3 months (for patients receiving a 3-months formulation) or 1 months (for
patients receiving a 1-month formulation) prior to Cycle 1 day 1.
3. Patients receiving a 6- or 12-months formulation of LHRH-therapy
4. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
5. Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
6. Pathological finding consistent with small cell carcinoma of the prostate
7. Liver or visceral organ metastasis
8. Known brain metastasis
9. Use of opiate analgesics for cancer-related pain, including codeine, tramadol, tilidin and others (see Appendix 9), currently or anytime within 4 weeks of Cycle 1 Day 1.
10. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
11. Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1
12. Radiation or radionuclide therapy for treatment of metastatic CRPC
13. Prior treatment with Abiraterone acetate or other CYP17 inhibitors (ketoconazole, TAK700, TOK001) or investigational agents targeting the androgen receptor for prostate cancer for more than 7 days
14. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole)
within 4 weeks of Cycle 1, Day 1
15. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
16. Bicalutamide (Casodex), nilutamide (andron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
17. Uncontrolled hypertension (systolic BP =160 mmHg or diastolic BP =95 mmHg). Patients with a history of hypertension are allowed provided that blood
pressure is controlled by anti-hypertensive treatment
18. Active or symptomatic viral hepatitis or chronic liver disease
19. History of pituitary or adrenal dysfunction
20. 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
21. Any condition that requires treatment with Digoxin, digitoxin, and other digitalis drugs
22. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
23. Other malignancy with a =30 % probability of recurrence within 24 months, except non-melanoma skin cancer.
24. Administration of an investigational therapy within 30 days of Cycle 1, Day 1
25. Any condition, which, in the opinion of the investigator, would preclude participation in this trial.

Study & Design

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