Clinical research study to evaluate the effectiveness and safety of a potential oral medication for subjects with metastatic castration resistant prostate cancer


Last updated date
Study Location
Urology Austin PLLC
Austin, Texas, 78745, United States

Study Website

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center


By email


[email protected]

Call Now

Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Who can take part in the study?

You may be able to join the TALAPRO-2 study if you meet the following criteria:

  • you have a diagnosis of metastatic castration-resistant prostate cancer
  • you are 18 years of age or older
  • you are willing to provide saliva, blood and tumor tissue samples for genetic testing
  • you are otherwise in reasonably good health

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

You will not be able to take part in the study if you have received:

  • systemic cancer treatment (treatment that enters the bloodstream to reach cells all over the body), not including androgen deprivation therapy and first-generation anti-androgens, since your metastatic castration-resistant prostate cancer diagnosis
  • treatment with enzalutamide, apalutamide or darolutamide (and certain other therapies used in the treatment of prostate cancer that your doctor will be able to check for you)
  • treatment with platinum-based chemotherapy within 6 months (from the last dose)

There are other requirements for participation in the study.  The study doctor will be able to explain these to you.


For Patients: Please visit the study website for more information

All other inquiries: Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center


[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.


Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

mCRPCClinical research study to evaluate the effectiveness and safety of a potential oral medication for subjects with metastatic castration resistant prostate cancer
  1. Austin, Texas
  2. Porto Alefre, RS
  3. Rio de Janeiro, RS
  4. Rio de Janeiro, RS
  5. Lyon Cedex 08,
  6. Lisboa,
  7. Chandler, Arizona
  8. Gilbert, Arizona
  9. Gilbert, Arizona
  10. Gilbert, Arizona
  11. Mesa, Arizona
  12. Mesa, Arizona
  13. Scottsdale, Arizona
  14. Tucson, Arizona
  15. Tucson, Arizona
  16. Beverly Hills, California
  17. Chula Vista, California
  18. Chula Vista, California
  19. Glendale, California
  20. Greenbrae, California
  21. La Mesa, California
  22. Loma Linda, California
  23. Loma Linda, California
  24. Long Beach, California
  25. Los Angeles, California
  26. Orange, California
  27. Palo Alto, California
  28. Rancho Mirage, California
  29. Rancho Mirage, California
  30. San Diego, California
  31. San Diego, California
  32. San Diego, California
  33. Aurora, Colorado
  34. Aurora, Colorado
  35. Aurora, Colorado
  36. Aurora, Colorado
  37. Aurora, Colorado
  38. Denver, Colorado
  39. Danbury, Connecticut
  40. New Milford, Connecticut
  41. Norwalk, Connecticut
  42. Altamonte Springs, Florida
  43. Bonita Springs, Florida
  44. Bradenton, Florida
  45. Brandon, Florida
  46. Cape Coral, Florida
  47. Celebration, Florida
  48. Clearwater, Florida
  49. Daytona Beach, Florida
  50. Fort Myers, Florida
  51. Fort Myers, Florida
  52. Fort Myers, Florida
  53. Fort Myers, Florida
  54. Gainesville, Florida
  55. Kissimmee, Florida
  56. Lakeland, Florida
  57. Largo, Florida
  58. Lecanto, Florida
  59. Naples, Florida
  60. New Port Richey, Florida
  61. Ocala, Florida
  62. Orange City, Florida
  63. Orlando, Florida
  64. Orlando, Florida
  65. Orlando, Florida
  66. Port Charlotte, Florida
  67. Saint Petersburg, Florida
  68. Sarasota, Florida
  69. Sarasota, Florida
  70. Spring Hill, Florida
  71. Tampa, Florida
  72. Tavares, Florida
  73. The Villages, Florida
  74. Venice, Florida
  75. Venice, Florida
  76. Vero Beach, Florida
  77. Wellington, Florida
  78. West Palm Beach, Florida
  79. Winter Park, Florida
  80. Athens, Georgia
  81. Atlanta, Georgia
  82. Atlanta, Georgia
  83. Atlanta, Georgia
  84. Atlanta, Georgia
  85. Fayetteville, Georgia
  86. Newnan, Georgia
  87. Newnan, Georgia
  88. Chicago, Illinois
  89. Chicago, Illinois
  90. Chicago, Illinois
  91. Chicago, Illinois
  92. Hinsdale, Illinois
  93. Hinsdale, Illinois
  94. Zion, Illinois
  95. Jeffersonville, Indiana
  96. Iowa City, Iowa
  97. Fairway, Kansas
  98. Westwood, Kansas
  99. Louisville, Kentucky
  100. New Orleans, Louisiana
  101. Baltimore, Maryland
  102. Saint Louis, Missouri
  103. Billings, Montana
  104. Billings, Montana
  105. Omaha, Nebraska
  106. Omaha, Nebraska
  107. Omaha, Nebraska
  108. Omaha, Nebraska
  109. Belleville, New Jersey
  110. Voorhees, New Jersey
  111. Albuquerque, New Mexico
  112. Farmington, New Mexico
  113. Bronx, New York
  114. Poughkeepsie, New York
  115. Syracuse, New York
  116. Cincinnati, Ohio
  117. Middleburg Heights, Ohio
  118. Oklahoma City, Oklahoma
  119. Clackamas, Oregon
  120. Clackamas, Oregon
  121. Hillsboro, Oregon
  122. Newberg, Oregon
  123. Portland, Oregon
  124. Portland, Oregon
  125. Portland, Oregon
  126. Springfield, Oregon
  127. Altoona, Pennsylvania
  128. Bethel Park, Pennsylvania
  129. Greensburg, Pennsylvania
  130. Lancaster, Pennsylvania
  131. Monroeville, Pennsylvania
  132. Pittsburgh, Pennsylvania
  133. Pittsburgh, Pennsylvania
  134. Pittsburgh, Pennsylvania
  135. Seneca, Pennsylvania
  136. Uniontown, Pennsylvania
  137. Washington, Pennsylvania
  138. Myrtle Beach, South Carolina
  139. Chattanooga, Tennessee
  140. Chattanooga, Tennessee
  141. Cleveland, Tennessee
  142. Harrogate, Tennessee
  143. Jefferson City, Tennessee
  144. Knoxville, Tennessee
  145. Knoxville, Tennessee
  146. Morristown, Tennessee
  147. Nashville, Tennessee
  148. Nashville, Tennessee
  149. Nashville, Tennessee
  150. El Paso, Texas
  151. Houston, Texas
  152. Round Rock, Texas
  153. Temple, Texas
  154. Farmington, Utah
  155. Salt Lake City, Utah
  156. Salt Lake City, Utah
  157. Salt Lake City, Utah
  158. South Jordan, Utah
  159. Fairfax, Virginia
  160. Fairfax, Virginia
  161. Seattle, Washington
  162. Seattle, Washington
  163. Madison, Wisconsin
  164. Madison, Wisconsin
  165. Pergamino, Buenos Aires
  166. Rosario, Santa FE
  167. Caba,
  168. Caba,
  169. Cordoba,
  170. Cordoba,
  171. Camperdown, New South Wales
  172. Darlinghurst, New South Wales
  173. Port Macquarie, New South Wales
  174. Auchenflower, Queensland
  175. Auchenflower, Queensland
  176. Brisbane, Queensland
  177. Chermside, Queensland
  178. South Brisbane, Queensland
  179. South Brisbane, Queensland
  180. Southport, Queensland
  181. Melbourne, Victoria
  182. North Melbourne, Victoria
  183. Brasschaat,
  184. Gent,
  185. Gent,
  186. Kortrijk,
  187. Ottignies,
  188. Yvoir,
  189. Rio de Janeiro, RJ
  190. Rio de Janeiro, RJ
  191. Rio de Janeiro, RJ
  192. Ijui, RS
  193. Lajeado, RS
  194. Porto Alegre, RS
  195. Porto Alegre, RS
  196. Porto Alegre, RS
  197. Rio de Janeiro, RS
  198. Rio de Janeiro, RS
  199. Barretos, SP
  200. Santo Andre, SP
  201. Santo Andre, SP
  202. Sao Paulo, SP
  203. Sao Paulo, SP
  204. Sao Paulo, SP
  205. Sao Paulo, SP
  206. Calgary, Alberta
  207. Ottawa, Ontario
  208. Chicoutimi, Quebec
  209. Montreal, Quebec
  210. Montreal, Quebec
  211. Sherbrooke, Quebec
  212. Santiago, Metropolitana
  213. Temuco, Region DE LA Araucania
  214. Temuco, Region DE LA Araucania
  215. Temuco, Region DE LA Araucania
  216. Vina del Mar, Valparaiso
  217. Vina del Mar, Valparaiso
  218. Hefei, Anhui
  219. Beiijng, Beijing
  220. Beijing, Beijing
  221. Beijing, Beijing
  222. Fuzhou, Fujian
  223. Xiamen, Fujian
  224. Wuhan, Hubei
  225. Wuhan, Hubei
  226. Nanjing, Jiangsu
  227. Suzhou, Jiangsu
  228. Nanchang, Jiangxi
  229. Shanghai, Shanghai
  230. Shanghai, Shanghai
  231. Shanghai, Shanghai
  232. Xi'an, Shanxi
  233. Chengdu, Sichuan
  234. Kunming, Yunnan
  235. Hangzhou, Zhejiang
  236. Hangzhou, Zhejiang
  237. Ningbo, Zhejiang
  238. Chongqing,
  239. Shanghai,
  240. Shanghai,
  241. Shanghai,
  242. Tianjin,
  243. Hradec Kralove,
  244. Ostrava-Poruba,
  245. Pardubice,
  246. Praha 10,
  247. Usti nad Labem,
  248. Helsinki,
  249. Helsinki,
  250. Helsinki,
  251. Kempele,
  252. Kuopio,
  253. Kuopio,
  254. Oulu,
  255. Tampere,
  256. Turku,
  257. Bayonne,
  258. Bayonne,
  259. Bordeaux Cedex,
  260. Bordeaux,
  261. LA ROCHE SUR YON cedex 9,
  262. Le Mans,
  263. Le Mans,
  264. Lyon CEDEX 08,
  265. Montpellier cedex 5,
  266. Paris Cedex 15,
  267. Paris,
  268. Strasbourg,
  269. Strasbourg,
  270. Suresnes Cedex,
  271. Suresnes,
  272. VILLEJUIF cedex,
  273. Erlangen, Bayern
  274. Duesseldorf,
  275. Erlangen,
  276. Hamburg,
  277. Heidelberg,
  278. Kirchheim,
  279. Muenster,
  280. Nuertingen,
  281. Ravensburg,
  282. Reutlingen,
  283. Weiden,
  284. Budapest,
  285. Budapest,
  286. Budapest,
  287. Budapest,
  288. Debrecen,
  289. Pecs,
  290. Haifa,
  291. Jerusalem,
  292. Tel Aviv,
  293. Bologna, BO
  294. Cremona, CR
  295. Meldola, FC
  296. Terni, TN
  297. Trento, TN
  298. Orbassano, TO
  299. Brescia,
  300. Napoli,
  301. Napoli,
  302. Nagoya, Aichi
  303. Hirosaki, Aomori
  304. Kashiwa, Chiba
  305. Matsuyama, Ehime
  306. Kure, Hiroshima
  307. Sapporo, Hokkaido
  308. Sapporo, Hokkaido
  309. Kanazawa, Ishikawa
  310. Yokohama, Kanagawa
  311. Yokosuka, Kanagawa
  312. Osaka-shi, Osaka
  313. Osakasayama, Osaka
  314. Suita, Osaka
  315. Hamamatsu, Shizuoka
  316. Meguro-ku, Tokyo
  317. Shinjuku-ku, Tokyo
  318. Chiba,
  319. Fukuoka,
  320. Kagoshima,
  321. Kumamoto,
  322. Tokushima,
  323. Yamagata,
  324. Yamagata,
  325. Goyang-si, Gyeonggi-do
  326. Goyang-si, Gyeonggi-do
  327. Busan,
  328. Daegu,
  329. Seoul,
  330. Seoul,
  331. Seoul,
  332. Seoul,
  333. Seoul,
  334. Seoul,
  335. Seoul,
  336. Seoul,
  337. Seoul,
  338. Tauranga, BAY OF Plenty
  339. Christchurch, Canterbury
  340. Hamilton, Waikato
  341. Auckland,
  342. Auckland,
  343. Gralum,
  344. Gralum,
  345. Lorenskog,
  346. Oslo,
  347. Trondheim,
  348. Trondheim,
  349. Arequipa,
  350. Lima,
  351. Lima,
  352. Lima,
  353. Lima,
  354. Brzozow,
  355. Gdynia,
  356. Konin,
  357. Otwock,
  358. Warsaw,
  359. Warszawa,
  360. Braga,
  361. Coimbra,
  362. Lisboa,
  363. Porto,
  364. Porto,
  365. Port Elizabeth, Eastern CAPE
  366. Johannesburg, Gauteng
  367. Johannesburg, Gauteng
  368. Johannesburg, Gauteng
  369. Cape Town, Western CAPE
  370. George, Western CAPE
  371. Kraaifontein, Cape Town, Western CAPE
  372. Santiago de Compostela, A Coruna
  373. Elche, Alicante
  374. L'Hospitalet de Llobregat, Barcelona
  375. Sabadell, Barcelona
  376. El Palmar, Murcia
  377. Barcelona,
  378. Barcelona,
  379. Madrid,
  380. Madrid,
  381. Madrid,
  382. Madrid,
  383. Goteborg,
  384. Stockholm,
  385. Umeå,
  386. Plymouth, Devon
  387. Bebington, Wirral
  388. Cornwall,
  389. Glasgow,
  390. Liverpool,
  391. London,
  392. London,
  393. London,
  394. Oxford,
18 Years+
Advanced Information
Descriptive Information
Brief Title  ICMJE Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
Brief Summary This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.
Detailed Description Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
To assess radiographic PFS in men with mCRPC (with no systemic treatments initiated after documentation of mCRCP) treated with talazoparib and enzalutamide vs. placebo plus enzalutamide
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Primary Purpose: Treatment
Condition  ICMJE mCRPC
Intervention  ICMJE
  • Drug: Talazoparib with enzalutamide
    Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
  • Drug: Placebo with enzalutamide
    Placebo plus enzalutamide 160 mg/day
Study Arms  ICMJE
  • Experimental: Combination arm
    Talazoparib plus enzalutamide
    Intervention: Drug: Talazoparib with enzalutamide
  • Active Comparator: Monotherapy arm
    Ezalutamide plus placebo
    Intervention: Drug: Placebo with enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 3, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2018)
Estimated Study Completion Date  ICMJE November 25, 2024
Estimated Primary Completion Date August 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate withoutsmall cell or signet cell features

Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be < 4).

For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status

Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1).

Surgically or medically castrated, with serum testosterone ? 50 ng/dL (? 1.73 nmol/L) at screening.

Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan.

Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:

  • Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments..
  • Soft tissue disease progression as defined by RECIST 1.1.
  • Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan.

Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory.

Eastern Cooperative Oncology Group (ECOG) performance status ? 1.

Life expectancy ? 12 months as assessed by the investigator.

Able to swallow the study drug and have no known intolerance to study drugs or excipients.

Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential.

Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.

Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient [or a legally acceptable representative/legal guardian] has been informed of all pertinent aspects of the study.

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state.

Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.

Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.

Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose).

Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2).

Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2).

Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2).

Clinically significant cardiovascular disease

Significant renal dysfunction as defined by any of the following laboratory abnormalities:

? Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via

Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening.

Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs:

  • Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis).
  • Albumin <2.8 g/dL

Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening).

Known or suspected brain metastasis or active leptomeningeal disease.

Symptomatic or impending spinal cord compression or cauda equina syndrome.

Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following:

  • Carcinoma in situ or non melanoma skin cancer
  • Any prior malignancies ?3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage.
  • Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator

Gastrointestinal disorder affecting absorption.

Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product.

Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Gender Eligibility Description:Men at least 18 years of age. For Japan, at least 20 years of age.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   New Zealand,   Norway,   Peru,   Poland,   Portugal,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03395197
Other Study ID Numbers  ICMJE C3441021
2017-003295-31 ( EudraCT Number )
TALAPRO-2 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Astellas Pharma Inc
Investigators  ICMJE
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP