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The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galeterone | Experimental |
| |
| Enzalutamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galeterone | Drug | 2550 mg galeterone tablets once daily PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-free survival | ≥ 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | ≥ 8 months | |
| Time to Initiation of Cytotoxic Chemotherapy | ≥ 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Skeletal-related Events | ≥ 8 months | |
| Safety measured by clinical safety laboratories and adverse events | ≥ 8 months | |
| Prostate Specific Antigen (PSA) Response ≥ 50% |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Oncology Hematology | Scottsdale | Arizona | 85258 | United States | ||
| University Of Arizona Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26908063 | Derived | Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821. |
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| Enzalutamide | Drug | 160 mg enzalutamide capsules once daily PO |
|
|
| ≥ 8 months |
| Time to PSA progression | ≥ 8 months |
| Time to ECOG deterioration | ≥ 8 months |
| Best Overall Response by RECIST 1.1 | ≥ 8 months |
| Tucson |
| Arizona |
| 85724 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| Prostate Oncology Specialists, Inc. | Marina del Rey | California | 90292 | United States |
| UC Davis Cancer Center | Sacramento | California | 95817 | United States |
| San Bernardino Urological Associates | San Bernardino | California | 92404 | United States |
| Urology Speciality Group | Torrance | California | 90505 | United States |
| University of Colorado Cancer Center Anschultz Cancer Pavilion | Aurora | Colorado | 80045 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States |
| Boca Raton Community Hospital, Inc. | Boca Raton | Florida | 33486 | United States |
| University of Florida Health Cancer Center | Orlando | Florida | 32806 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| First Urology | Jeffersonville | Indiana | 47130 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70115 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| University of Maryland Greenenbaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20307 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Urology Cancer Center and GU Research Network | Omaha | Nebraska | 68130 | United States |
| Coastal Urology Associates | Brick | New Jersey | 08724 | United States |
| Brooklyn Urology Research Group | Brooklyn | New York | 11215 | United States |
| Advanced Urology Centers of New York | Plainview | New York | 11803 | United States |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | United States |
| Associated Medical Professionals of NY | Syracuse | New York | 13210 | United States |
| University of North Carolina Lineberger Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Carolina Urology Partners, PLLC | Charlotte | North Carolina | 28277 | United States |
| Carolina Urology Partners | Concord | North Carolina | 28025 | United States |
| The Urology Group | Cincinnati | Ohio | 45212 | United States |
| Clinical Research Solutions | Middleburg Heights | Ohio | 44130 | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Associates Clinical Research | Nashville | Tennessee | 37209 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| Texas Oncology/Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| St. George Private Hospital, Oncology Day Care Centre | Kogarah | New South Wales | 2217 | Australia |
| Ashford Cancer Centre/Adelaide Cancer Centre Research | Kurralta Park | New South Wales | 5037 | Australia |
| North Coast Cancer Institute | Port Macquarie | New South Wales | 2444 | Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Macquarie University | Sydney | New South Wales | 2109 | Australia |
| Peninsula Specialist Centre | Kippa-Ring | Queensland | 4102 | Australia |
| ICON Cancer Care | Southport | Queensland | 4215 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Ashford Cancer Centre/Adelaide Cancer Centre Research | Kurralta Park | South Australia | 5037 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Centre | East Bentleigh | Victoria | 3165 | Australia |
| Peter MacCallum Cancer Centre | East Melbourne | Victoria | 3002 | Australia |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Jules Bordet Institute Clinique d'Oncologie Medicale | Brussels | B-1000 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | B-9000 | Belgium |
| Jessa Ziekenhuis | Hasselt | B-3500 | Belgium |
| CHU Sart Tilman | Liège | 4000 | Belgium |
| British Columbia Cancer | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer | Vancouver | British Columbia | V5Z 4E6 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier De I'Universite de Montreal | Montreal | Quebec | H2L 4M1 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 3S1 | Canada |
| Centre Paul Papin | Angers | 49055 | France |
| Institut Sainte Catherine | Avignon | 84918 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| Centre François Baclesse | Caen | 14076 | France |
| Service de Médecine Interne Onco-Hématologie | La Roche-sur-Yon | 85925 | France |
| Clinique Victor Hugo Centre Jean Bernard | Le Mans | 72000 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Hôpital Edouard Herriot | Lyon | Cedex 03 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Centre René Gauducheau | Saint-Herblain | 44805 | France |
| Institut de Cancérologie de l'Ouest | Saint-Herblain | 44805 | France |
| Institut de Cancerlogie de la Loire | Saint-Priest-en-Jarez | 42271 | France |
| Institut Gustave-Roussy | Villejuif | 94805 | France |
| Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo | Arezzo | 52100 | Italy |
| Unità Operativa di Oncologia Ospedale Civile degli Infe | Faenza (RA) | 48018 | Italy |
| Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica | Meldola (FC) | 47014 | Italy |
| AOU "S. Luigi", SCDU Oncologia Medica | Orbassano (Torino) | 10043 | Italy |
| Az. Ospedaliera San Camillo-Forlanini | Roma | 00152 | Italy |
| University of Turin | Torino | 10126 | Italy |
| Santa Chiara Hospital | Trento | 38122 | Italy |
| Hospital Clínic i Provincial de Barcelona-Oncology | Barcelona | 08036 | Spain |
| Instituto Catalan de Oncologia (Hospital Durans i Reynals) | Barcelona | 08908 | Spain |
| Hospital General Universitario de Elche | Elche | 3203 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Spanish National Cancer Research Centre | Madrid | 28050 | Spain |
| Fundación Althaia Manresa | Manresa | 08243 | Spain |
| Unidad Cnio Ibima de Investigacion en Prostata | Málaga | Spain |
| Hospital Son Espases - Oncología | Palma de Mallorca | 07010 | Spain |
| Hospital Clinico Universitario de Navarra | Pamplona | 31008 | Spain |
| Consorci Hospitalari de Parc Taulí | Sabadell | 08208 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| IVO-Oncología Médica | Valencia | 46009 | Spain |
| CR-UK Institute for Cancer Studies | Birmingham | England | B15 2PR | United Kingdom |
| Sussex Cancer Centre | Brighton | England | BN2 5BE | United Kingdom |
| University College of London Hospitals | London | England | NWI 2PG | United Kingdom |
| Guy's and St. Thomas' NHS Foundation Trust | London | England | SE1 9RT | United Kingdom |
| Southampton General Hospital | Southampton | England | SO16 6YD | United Kingdom |
| University of Surrey Post Graduate Medical Hospital | Surrey | England | GU2 7WG | United Kingdom |
| Royal Marsden Hospital | Surrey | England | SM2 5PT | United Kingdom |
| The Royal Cornwall Hospital | Truro | England | TR1 3LJ | United Kingdom |
| The Beatson West of Scotland Cancer Centre | Glasgow | Scotland | G12 0YN | United Kingdom |
| Velindre Hospital | Cardiff | Wales | CF14 2TL | United Kingdom |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C500627 | 3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene |
| C540278 | enzalutamide |
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