None listed
Conditions
Interventions
THE PATIENT POPULATION WILL BE CONSIST OF ADULT MEN HO HAVE HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED ADENOCARCINOMA OF THE PROSTAT AND DOCUMENTED PROGRESSIVE METASTATIC DISEASE, DESPITE CASTRATE LEVE
Sponsors
Millennium Pharmaceuticals, Inc.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. MALE PATIENTS 18 YEARS OR OLDER. 2. VOLUNTARY WITTEN CONSENT, GIVEN BEFORE PERFORMANCE OF ANY STUDY-RELATED PROCEDURE NOT PART OF STANDARD MEDICAL CARE, AND WITH THE UNDERSTANDING THAT CONSENT MAY BE WITHDRAWN AT ANY TIME WITHOUT PREJUDICE TO FUTURE MEDICAL CARE. 3. ADENOCARCINOMA OF THE PROSTATE EITHER HISTOLOGICALLY OR CYTOLOGICAL CONFIRMED. 4. METASTATIC DISEASE RADIOGRAPHICALLY DOCUMENTED BY CT/MRI OR BONE SCAN. PATIENTS WITH VISCERAL COMPROMISE, SUCH AS THOSE WITH VISCERAL METASTASES TO THE LUNG, LIVER, OR KIDNEY, WILL BE EXCLUDED. 5. PD BASED ON PSA AND/OR RADIOGRAPHIC CRITERIA, DEFINED AS FOLLOWS: • RADIOGRAPHIC DISEASE PROGRESSION BASED ON RECIST 1.1 (REFER TO SECTION 15.1) IN PATIENTS WITH MEASURABLE SOFT TISSUE LESIONS. FOR BONE DISEASE, PROGRESSION WIL BE ASSESSED FOLLOWING RECOMMENDATIONS BY THE PROSTATE CANCER WORKING GROUP (PCWG2; REFER TO SECTION 15.1); APPEARANCE OF 2 OR MORE NEW IN LESIONS ON BONE SCAN CONFIRMED, IF NECESSARY, BY OTHER IMAGING MODALITIES (SUCH AS CT SCAN OR MRI), IF RESULTS OF THE BONE SCANS ARE AMBIGUOUS.
Exclusion criteria
Exclusion criteria: 1. PRIOR THERAPY WITH ORTERONEL, KETOCONAZOLE, AMINOGLUTETHIMIDE, OR ABIRATERONE. 2. KNOWN HYPERSENSITIVITY TO COMPOUNDS RELATED TO ORTERONEL, TO ORTERONEL EXCIPIENTS, TO PREDNISONE, OR TO GnRH ANALOGUE. 3. THERAPY WITH BICALUTAMIDE WITHIN 6 WEEKS OF THE FIRST DOSE OF STUDY DRUG. ALL OTHER ANTIANDROGEN THERAPY IS EXCLUDED WITHIN 4 WEEKS PRIOR TO FIRST DOSE OF STUDY DRUG. 4. CONTINUOUS DAILY USE OF ORAL PREDNISONE OR ORAL DEXAMETHASONE FOR MORE THAN 14 DAYS WITHIN 3 MONTHS PRIOR TO SCREENING (INHALED, NASAL, AND LOCAL STEROIDS ARE ALLOWED [eg, JOINT INJECTION]). 5. PRIOR CHEMOTHERAPY FOR PC, WITH THE EXCEPTION OF NEOADJUVANT/ADJUVANTED THERAPY AS PART OF INITIAL PRIMARY TREATMENT FOR LOCAL DISEASE THAT WAS COMPLETED 2 OR MORE YEARS PRIOR O SCREENING. 6. EXPOSURE TO RADIOISOTOPE THERAPY WITHIN 4 WEEKS OF RECEIVING THE FIRST DOSE OF STUDY DRUG; EXPOSURE TO EXTERNAL BEAM RADIATION WITHIN 2 WEEKS OF START OF SCREENING UNTIL RECEIVING THE FIRST DOSE OF STUDY DRUG. 7. DOCUMENTED CENTRAL NERVOUS SYSTEM METASTASES.
Countries
Australia, Belgium, Canada, Czech Republic, Estonia, Finland, France, Greece, Hungary, Italy, Netherlands, New Zealand, Poland, Singapore, Slovakia, Turkey, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed