Clinical trial NCT03148795: A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
Official title: TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2017-05-11
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without signet cell, or small cell features.
3. Patients must have measurable soft tissue disease per RECIST 1.1
4. DNA damage repair deficiency as assessed centrally by a gene mutation biomarker panel (testing of de novo or archival tumor tissue (via central laboratory) or prior historical testing (with Sponsor approval) using the Foundation Medicine, FoundationOne CDx™ NGS gene panel test.
5. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
6. Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.
7. Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).
8. Progressive disease at study entry defined as 1 or more of the following 3 criteria:

   * A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2 ng/mL) if qualifying solely by PSA progression.
   * Soft tissue disease progression as defined by RECIST 1.1.
   * Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.
9. Metastatic disease.
10. Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic (non castrate or castrate) prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
11. Documented disease progression (either radiographic or biochemical) on at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) for the treatment of metastatic CRPC, irrespective of prior NHT treatment for non castrate prostate cancer or nonmetastatic (M0) CRPC.
12. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
14. Estimated life expectancy of ≥ 6 months as assessed by the investigator.
15. Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.
16. Must use a condom when having sex from the time of the first dose of study drug through 4 months after last dose of study drug. A highly effective form of contraception must be used from the time of the first dose of study drug through 4 months after last dose of study drug when having sex with a non pregnant female partner of childbearing potential.
17. Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.
18. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

1. 1. Use of systemic chemotherapeutic (including but not limited to taxanes), hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
2. Prior treatment with a PARP inhibitor, cyclophosphamide, or mitoxantrone chemotherapy. Patients who discontinued prior platinum based chemotherapy \<=6 months prior to screening or whose disease previously progressed on platinum based therapy at any time in the past are also excluded.
3. Treatment with any concurrent cytotoxic chemotherapy or investigational drug(s) within 4 weeks or 5 half lives of the drug (whichever is longer) before Day 1 and/or during study participation
4. Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
5. Major surgery within 2 weeks before day 1.
6. Clinically significant cardiovascular disease.
7. Significant renal, hepatic, or bone marrow organ dysfunction.
8. Known or suspected brain metastasis or active leptomeningeal disease.
9. Symptomatic or impending spinal cord compression or cauda equina syndrome.
10. Prior diagnosis of myelodysplastic syndrome or acute myeloid leukemia
11. History of another cancer within 3 years before enrollment with the exception of nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
12. Gastrointestinal disorder affecting absorption.
13. Current or anticipated use within 7 days prior to first dose of study drug or anticipated use during the study of the following P gp inhibitors (amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, verapamil, and valspodar).
14. Any other acute or chronic medical or psychiatric condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of data, in the opinion of the investigator or sponsor, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that 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.
15. 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.
16. Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 4 months after the last dose of investigational product.

Primary outcomes:
measure: Best Objective Response Rate (ORR)
timeFrame: From first dose of study drug to best overall soft tissue response CR or PR (maximum duration of 25 months)
Secondary outcomes:
measure: Time to Objective Response
timeFrame: From first dose of study drug to first objective response (maximum duration of 25 months)
measure: Duration of Response (DOR)
timeFrame: From the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause without evidence of radiographic progression, whichever occurs first (maximum duration of 25 months)
measure: Percentage of Participants With Prostate-Specific Antigen (PSA) Response of Greater Than or Equal to (>=) 50 Percentage (%)
timeFrame: From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)
measure: Percentage of Participants With Conversion of Circulating Tumor Cell (CTC) Count
timeFrame: Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months
measure: Percentage of Participants With a Null CTC Count
timeFrame: Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months
measure: Percentage of Participants With Baseline CTC Count <5 CTC Showed Increased CTC Counts at Any Time on Study
timeFrame: Baseline to anytime on study during final analysis of the outcome measure, up to maximum duration of 25 months
measure: Time to Prostate-Specific Antigen (PSA) Progression
timeFrame: From the date of first dose of study treatment until confirmed PSA progression or start of new anticancer treatment given after the first dose of study treatment (maximum duration of 25 months)
measure: Radiographic Progression-Free Survival (PFS)
timeFrame: From date of first dose of study drug to first objective evidence of radiographic progression or death without documented radiographic progression, whichever occurs first (maximum duration of 25 months)
measure: Overall Survival (OS)
timeFrame: From first dose of study treatment up to death due to any cause during study or date of last contact (approximately 36 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug up to 28 days after last dose of study drug (study treatment was approximately for 36 months, safety follow up to approximately 37 months)
measure: Number of Participants With Permanent Treatment Discontinuation Due to Adverse Events
timeFrame: During study treatment (approximately up to 36 months)
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: During study treatment (approximately up to 36 months)
measure: Number of Participants With Shift in Laboratory Parameter Values (Hematology) From Grade Less Than Equal to (<=) 2 at Baseline to Grade 3 or 4 Post-baseline
timeFrame: During study treatment (approximately up to 36 months)
measure: Number of Participants With Shift in Laboratory Parameter Values (Chemistry) From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline
timeFrame: During study treatment (approximately up to 36 months)
measure: Number of Participants With Dose Modification
timeFrame: During study treatment (approximately up to 36 months)
measure: Time to Deterioration in Pain Symptom Scores
timeFrame: Baseline till final analysis of the outcome measure, up to maximum duration of 25 months
measure: Change From Baseline in Participant Reported Pain Scores Per BPI-SF Question 3
timeFrame: Baseline, Week 1, 3, 5, 7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Change From Baseline in European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) Visual Analogue Scores (VAS)
timeFrame: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Number of Participants With 5 Response Levels for EQ-5D-5L Mobility Domain
timeFrame: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Number of Participants With 5 Response Levels for EQ-5D-5L Self-Care Domain
timeFrame: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Number of Participants With 5 Response Levels for EQ-5D-5L Usual Activity Domain
timeFrame: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Number of Participants With 5 Response Levels for EQ-5D-5L Pain and Discomfort Domain
timeFrame: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Number of Participants With 5 Response Levels for EQ-5D-5L Anxiety and Depression Domain
timeFrame: Baseline, Week 1, 3, 5,7, 9, 13, 17, 21, 25, 37, 49, 61, 73, 85, 97, Follow-up Visit (28 days after last dose) [maximum duration of 25 months]
measure: Pre-dose Plasma Concentration (Ctrough) of Talazoparib
timeFrame: Pre-dose at Week 1, 5, 9 and 13
measure: Post-dose Plasma Concentration (Ctrough) of Talazoparib
timeFrame: 2 hours post-dose at Week 1 and 5
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Lancaster
country: United States
facility: City of Hope-Antelope Valley
state: California
city: Orange
country: United States
facility: UC Irvine Health Investigational Drug Pharmacy
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates-SD
state: California
city: San Diego
country: United States
facility: Sharp Outpatient Infusion Therapy Center
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Newnan
country: United States
facility: Piedmont Cancer Institute, PC
state: Georgia
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - South County
state: Missouri
city: Saint Louis
country: United States
facility: Christian Hospital North East
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center - St. Peters
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical Center - New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center-New York Presbyterian Hospital
state: New York
city: Albemarle
country: United States
facility: Levine Cancer Institute-Albermarle
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute-Pineville
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute-Southpark
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute-University
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute-Ballantyne
state: North Carolina
city: Gastonia
country: United States
facility: Levine Cancer Institute- Gaston
state: North Carolina
city: Lincolnton
country: United States
facility: Levine Cancer Institute-Lincolnton
state: North Carolina
city: Monroe
country: United States
facility: Levine Cancer Institute-Monroe
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Parkway Surgery Center
state: South Carolina
city: Rock Hill
country: United States
facility: Levine Cancer Institute-Rock Hill
state: South Carolina
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
state: Texas
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Edmonds
country: United States
facility: Swedish Cancer Institute Edmonds Campus
state: Washington
city: Issaquah
country: United States
facility: Swedish Cancer Institute Issaquah Campus
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Hospital/Medical College of Wisconsin
state: Wisconsin
city: Darlinghurst
country: Australia
facility: Medical Imaging St Vincent's Hospital Sydney
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney, The Kinghorn Cancer Centre
state: New South Wales
city: Westmead
country: Australia
facility: PRP Diagnostic Imaging
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Cairns
country: Australia
facility: Liz Plummer Cancer Care Center
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care
state: Queensland
city: South Brisbane
country: Australia
facility: Intergrated Clinical Oncology Network (ICON)
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Care Southport
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health Pathology Service
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health
state: Victoria
city: Heidelberg
country: Australia
facility: Olivia Newton John Cancer Wellness & Research Centre Austin Health
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz, Barmherzige Schwestern
state: Upper Austria
city: Linz
country: Austria
facility: Vinzenz Pathologieverbund
state: Upper Austria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH, Elisabethinen
state: Upper Austria
city: Salzburg
country: Austria
facility: Paracelsus Medical University, SALK
city: Vienna
country: Austria
facility: Isotopix-Ambulatorium fur Nuklearmedizin
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Vienna
country: Austria
facility: Diagnosezentrum Meidling
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Sint-Lucas
city: Leuven
country: Belgium
facility: UZ Leuven, Campus Gasthuisberg
city: Ijui
country: Brazil
facility: Hospital de Caridade de Ijui
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre-HCPA
state: RS
city: Barretos
country: Brazil
facility: Fundacao Pio XII-Hospital de Cancer de Barretos
state: SAO Paulo
city: Jau
country: Brazil
facility: Fundacao Doutor Amaral Carvalho
state: SAO Paulo
city: Angers Cedex 02
country: France
facility: ICO-Site Paul Papin
city: Besancon
country: France
facility: CHRUBesangon-H6pital Jean Minjoz
city: Bordeaux cedex
country: France
facility: Institut Bergonie, Service d'Oncologie
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Departemental Les Oudairies
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo-Centre Jean Bernard
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe
city: Suresnes Cedex
country: France
facility: Hopital Foch Service Oncologie
city: VILLEJUIF cedex
country: France
facility: Institut Gustave Roussy
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mannheim
country: Germany
facility: Medizinische Fakultat Mannheim der Universitat Heidelberg
city: Munster
country: Germany
facility: Universitatsklinikum Munster
city: Nuertingen
country: Germany
facility: Studienpraxis Urologie
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, "C" Belgyogyaszati-Onkologiai es Klinikai Farmakogogiai Osztaly
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Nyiregyhaza
country: Hungary
facility: Szabolcs- Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
state: Forli - Cesena
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Rome
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria S. Luigi Gonzaga-SCDU Oncologia Medica
state: Torino/piemonte
city: Mestre
country: Italy
facility: AULSS3 Serenissima - Ospedale dell'Angelo - Oncologia Medica
state: Venezia
city: Cremona
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)
city: Napoli
country: Italy
facility: SD Oncologia Clinica Sperimentale di Uro-Ginecologia
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitari di Parma - U.O. Oncologia Medica
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma - U.O. Oncologia Medica
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud UMC
state: THE Netherlands
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Malaga
country: Spain
facility: Hospital Virgen de la Victoria
state: Malga
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra-Oncology Service
state: Navarra
city: Barcelona
country: Spain
facility: Hospital General Vall D'Hebron-Oncology Service
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid-Oncology Service
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia (IVO-FINCIVO)
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: Middlesex
city: Sutton
country: United Kingdom
facility: The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust , Sycamore House
state: Surrey
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Mehra N, Fizazi K, de Bono JS, Barthelemy P, Dorff T, Stirling A, Machiels JP, Bimbatti D, Kilari D, Dumez H, Buttigliero C, van Oort IM, Castro E, Chen HC, Di Santo N, DeAnnuntis L, Healy CG, Scagliotti GV. Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. Oncologist. 2022 Oct 1;27(10):e783-e795. doi: 10.1093/oncolo/oyac172.
citation: de Bono JS, Mehra N, Scagliotti GV, Castro E, Dorff T, Stirling A, Stenzl A, Fleming MT, Higano CS, Saad F, Buttigliero C, van Oort IM, Laird AD, Mata M, Chen HC, Healy CG, Czibere A, Fizazi K. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 2021 Sep;22(9):1250-1264. doi: 10.1016/S1470-2045(21)00376-4. Epub 2021 Aug 10.