Status:
COMPLETED
Analyze the Predictive Value of Gene TMPRSS2-ETS in Response to Enzalutamide in Patients With Prostate Cancer
Lead Sponsor:
Spanish Oncology Genito-Urinary Group
Collaborating Sponsors:
Astellas Pharma Inc
Apices Soluciones S.L.
Conditions:
Hormone-refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Prostate cancer is the most common non-skin tumor diagnosed in men and the second leading cause of cancer death in men in Western countries. Between 10-20% of patients are diagnosed at metastatic sta...
Eligibility Criteria
Inclusion
- Patients aged 18 years and above, willing and able to provide written informed consent.
- Prostate adenocarcinoma with histological or cytological confirmation without neuroendocrine differentiation nor small cell characteristics
- Androgen deprivation therapy with GnRH analogs or bilateral orchiectomy (pharmacological or surgical castration). Patients without bilateral orchiectomy must follow a GnRH analog therapy during the trial.
- Testosterone serum level \<= 1,73 nmol/L (50 ng/dL) in screening visit.
- Patients under bisphosphonate therapy must have received stable doses for the last 4 weeks.
- Progression disease at inclusion, defined by one or more of the following three criteria during androgen deprivation therapy (according with the criterion nº 3): - PSA progression defined as two elevation of the PSA serum level with \>=1 week between each measure. Patients who have received an antiandrogen must present disease progression (\>=4 weeks since the last dose of flutamide or \>=6 weeks since the last dose of bicalutamide or nilutamide). PSA value in screening visit must be \>=2 μg/L (2 ng/mL). - Soft tissue progression defined by RECIST 1.1 criteria - Bone lesion progression defined by PCWG2 criteria, with two or more new lesions in a scintigraphy
- Metastatic disease with bone lesions detected by scintigraphy, or measurable soft tissue lesions by CT/MR. Patients with ganglionar disease will be suitable if they have at least one ganglionar lesion with smallest diameter \> 2,5 cm.
- Patients without previous cytotoxic chemotherapy for prostate cancer
- Patients without previous abiraterone acetate therapy for prostate cancer - - Asymptomatic patient or mild symptomatic about prostate cancer, (answer in the question nº 3 of the Brief Pain Inventory Short From \< 4) 11. ECOG = 0-1.
- Life expectancy of at least 6 months
- Patient must be able to swallow the investigation product and to follow the protocol requirements.
- Biomarker study informed consent
Exclusion
- Active infection or other medical condition which, in the opinion of the investigator, would preclude participation in this trial.
- Known brain metastasis or leptomeningeal active involvement
- Other malignancy in the last five years, except non-melanoma skin cancer treated and resolved.
- Hematologic parameters: - Absolute neutrophil count \<=1500/μL - Platelet count \<100 000/μL - Haemoglobin \< 5,6 mmol/L (9 g/dL)
- Liver function: Serum bilirubin, SGPT/ALT or SGOT/AST \> 2,5 x ULN
- Renal function: Creatinine \>177 μmol/L (2 mg/dL).
- Serum albumin \<30 g/L (3,0 g/dL)
- History of epilepsy or other medical condition which could cause an epileptic crisis as syncope or transient ischemic attack in the last twelve months.
- Clinically significant cardiovascular disease.
- Known gastrointestinal (GI) disease that could interfere with the GI absorption.
- Significant surgery within 4 weeks before enrollment.
- Use of opioids to control cancer pain within 4 weeks before enrollment.
- Radiation therapy for treatment of the primary tumor in the last 3 weeks before enrollment
- Radiation therapy for treatment of metastases in the last two months
- Radionuclide therapy for treatment of bone metastasis
- Prior flutamide treatment within 4 weeks before enrollment
- Bicalutamide or nilutamide therapy within 6 weeks before enrollment
- 5-a reductase inhibitors, estrogen o cyproterone therapy within 4 weeks before enrollment
- Biologic therapy or other antitumoral drugs for the treatment of CRPC in the last 4 weeks
- History of cancer progression with ketoconazole
- Prior therapy or enrollment in a trial with an investigational product which blocks androgen synthesis (abiraterone, TAK-700, TAK-683, TAK-448) or blocks androgen receptors (ARN507, BMS 641988).
- Included in a previous trial with enzalutamide (MDV3100).
- Administration of an investigational drug in the last 4 weeks before enrollment
- Use of phytotherapy products which hormonal activity against prostate cancer or which reduce PSA levels, or systemic corticosteroids in a dose greater than the equivalent of prednisone 10mg/day, within 4 weeks before enrollment
- Hereditary fructose intolerance
- Any condition which, in the opinion of the investigator, would preclude participation in this trial.
Key Trial Info
Start Date :
February 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT02288936
Start Date
February 5 2015
End Date
July 22 2019
Last Update
September 24 2019
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120
2
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, Spain, 08916
3
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
4
Hospital Parc Taulí
Barcelona, Spain