None listed
Conditions
Interventions
APROXIMATELY 1200 ELIGIBLE PATIENTS WITH METASTATIC CRPC WILL BE RANDOMLY ASSIGNED IN A 2:1 RATIO TO 1 OF 2 TREATMENT GROUPS: TREATMENT GROUP A (TASQUINIMOD 0.25, 0.5, OR 1 MG/DAY, N=800) OR TREATMEN
N=400).
A SCHEMATIC OF THE STUDY DESIGN IS PRESENTED IN FIGURE 4-1.
RANDOMIZATION WILL BE STRATIFIED BY KARNOFSKY SCORE (APPENDIX 4) (≥
90% VERSUS <90%), PRESENCE OR ABSENCE OF VISCERAL DISEASE (ALL SOFT TISSUE EXCEPT LYMPH NODES AND LOCAL RECURRENCE) AND GEOGRAPHIC REGION OF ENROLLMENT (NORTH AMERICA, EUROPE, MIDDLE EAST AND AFRICA
ASIA-PACIFIC
AND LATIN AMERICA). STRATIFICATION WILL ENSURE THAT THERE IS NO UNEVENNESS IN TREATMENT ALLOCATION WITHIN THE SPECIFIED LEVELS OF THESE FACTORS TO AVOID CONFOUNDING THE TREATMENT EFFECT.
THE STUDY
Sponsors
ACTIVE BIOTECH AB,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. AGE AT LEAST 18 YEARS AT TIME OF SIGNING THE ICF. FOR PATIENTS IN TAIWAN THE MINIMUM AGE IS 20 YEARS. 2. HISTOLOGICALLY CONFIRMED DIAGNOSIS OF ADENOCARCINOMA OF THE PROSTATE. 3. EVIDENCE OF BONE METASTATIC DISEASE ON RADIOGRAPHIC EXAMINATION, WHETHER FROM BONE SCAN (BONE LESIONS) OR OTHER IMAGING MODALITY. 4. CASTRATE LEVELS OF SERUM TESTOSTERONE (≤ 50 NG/DL OR 1.7 nmol/L). 5. EVIDENCE OF PROGRESSIVE DISEASE AFTER CASTRATION LEVELS OF TESTOSTERONE HAVE BEEN ACHIEVED, DEFINED BY ANY OF THE FOLLOWING CRITERIA: • INCREASING SERUM PSA LEVELS, THE MOST RECENT VALUE ≥ 2 NG/ML. (INCREASING LEVELS MUST BE CONFIRMED BY 3 CONSECUTIVE PSA MEASUREMENTS WITHIN 15 MONTHS [PREFERABLY WITH 14 DAYS, BUT WITH AT LEAST 7 DAYS BETWEEN EACH MEASUREMENT]). • PROGRESSION OF SOFT TISSUE METASTASIS DOCUMENTED WITHIN 6 WEEKS OF ENROLLMENT BY COMPUTED TOMOGRAPHY (CT) SCAN OR MAGNETIC RESONANCE IMAGING MRI) SCAN. • PROGRESSION OF BONE DISEASE (AT LEAST 1 NEW BONE LESION AS MEASURED BY BONE SCAN WITHIN THE PAST 12 WEEKS) 6. KARNOFSKY SCORE ≥ 70%.
Exclusion criteria
Exclusion criteria: 1. PRIOR CYTOTOXIC CHEMOTHERAPY FOR THE TREATMENT OF PROSTATE CANCER WITHIN 2 YEARS. 2. PREVIOUS ANTICANCER THERAPY USING RADIATION, BIOLOGICS OR VACCINES INCLUDING SIPULEUCEL-T (PROVENGE), ABIRATERONE OR MDV3100 WITHIN 4 WEEKS PRIOR TO THE START OF STUDY TREATMENT. IF RADIATION THERAPY IS APPLIED AFTER THE BASELINE SCAN, A NEW BASELINE SCAN NEEDS TO BE DONE AT LEAST 4 WEEKS AFTER THE RADIATION THERAPY. 3. PREVIOUS THERAPY WITH ANTIANDROGENS WITHIN 4 WEEKS (WITHIN 6 WEEKS FOR BICALUTAMIDE, eg, CASODEX ®). 4. CONCURRENT USE OF OTHER ANTICANCER AGENTS OR TREATMENTS, WITH THE FOLLOWING EXCEPTIONS: • ONGOING TREATMENT WITH LHRH AGONISTS OR ANTAGONISTS, DENOSUMAB (PROLIA) O BISPHOSPHONATES (eg, ZOLEDRONIC ACID) IS ALLOWED. ONGOING TREATMENT SHOULD BE KEPT AT A STABLE SCHEDULE; HOWEVER, IF MEDICALLY REQUIRED, A CHANGE OF DOSE, COMPOUND, OR BOTH IS ALLOWED. 5. ANY TTRATMENT MODALITIES INVOLVING MAJOR SURGERY WITHIN 4 WEEKS PRIOR TO THE START OF STUDY TREATMENT. 6. PROSTATE CANCER PAIN THAT REQUIRES ONGOING TREATMENT WITH NARCOTICS ANALGESICS OR WARRANTS THE INITIATION OF RADIO- OR CHEMOTHERAPY.
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Estonia, France, Germany, Greece, India, Israel, Italy, Korea North, Lebano, Lithuania, Mexico, Netherlands, New Zealand, Panama, Poland, Romania, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed