177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

469

Participants

Timeline

Start Date

June 15, 2021

Primary Completion Date

October 2, 2022

Study Completion Date

September 30, 2026

Conditions
Prostatic Neoplasms
Interventions
DRUG

177Lu-PSMA-617

administered intravenously once every 6 weeks (1 cycle) for 6 cycles

DRUG

68Ga-PSMA-11

single intravenous dose of approximately 150 MBq. Administered dose must not be lower than 111 MBq or higher than 185 MBq (3 - 5 mCi).

DRUG

ARDT

administered orally on a continuous basis, as per package insert and guidelines

Trial Locations (72)

1011

Novartis Investigative Site, Lausanne

1090

Novartis Investigative Site, Vienna

1200

Novartis Investigative Site, Brussels

4000

Novartis Investigative Site, Liège

4020

Novartis Investigative Site, Linz

5404

Novartis Investigative Site, Baden

6020

Novartis Investigative Site, Innsbruck

8091

Novartis Investigative Site, Zurich

8800

Novartis Investigative Site, Roeselare

9000

Novartis Investigative Site, Ghent

10016

NYU Laura and Isaac Perlmutter Cancer Center, New York

10017

Memorial Sloan Kettering Cancer Ctr, New York

10029

Mount Sinai Hosp School of Med, New York

15706

Novartis Investigative Site, Santiago Compostela

17176

Novartis Investigative Site, Stockholm

23502

Virginia Oncology Associates, Norfolk

24014

Onco Hemato Asso of SE Virginia, Roanoke

27710

Duke Univ Medical Center, Durham

28009

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Majadahonda

29010

Novartis Investigative Site, Málaga

30120

Novartis Investigative Site, El Palmar

31008

Novartis Investigative Site, Pamplona

32610

University of Florida, Gainesville

33076

Novartis Investigative Site, Bordeaux

37203

Sarah Cannon Research Institute, Nashville

41013

Novartis Investigative Site, Seville

43221

The Ohio State University Comprehensive Cancer Center, Columbus

45147

Novartis Investigative Site, Essen

46009

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

49055

Novartis Investigative Site, Angers

53226

Medical College Of Wisconsin, Milwaukee

63011

Novartis Investigative Site, Clermont-Ferrand

63110

WA Uni School Of Med, St Louis

68130

Urology Cancer Center PC, Omaha

68154

Nebraska Cancer Specialists, Omaha

69373

Novartis Investigative Site, Lyon

70112

Tulane Uni Health Sciences Center, New Orleans

75970

Novartis Investigative Site, Paris

77030

Uni Of TX MD Anderson Cancer Cntr, Houston

80218

Rocky Mountain Cancer Centers, Denver

80377

Novartis Investigative Site, München

83310

Novartis Investigative Site, Bratislava

84106

Utah Cancer Specialists, Salt Lake City

94800

Novartis Investigative Site, Villejuif

98109

Seattle Cancer Care Alliance, Seattle

02115

Dana Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Med Ctr, Boston

V5Z 4E6

Novartis Investigative Site, Vancouver

H2W 1T8

Novartis Investigative Site, Montreal

H3T 1E2

Novartis Investigative Site, Montreal

779 00

Novartis Investigative Site, Olomouc

6500HB

Novartis Investigative Site, Nijmegen

6229 HX

Novartis Investigative Site, Maastricht

3584 CX

Novartis Investigative Site, Utrecht

44-101

Novartis Investigative Site, Gliwice

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona

413 45

Novartis Investigative Site, Gothenburg

221 85

Novartis Investigative Site, Lund

GU2 7XX

Novartis Investigative Site, Guildford

SM2 5PT

Novartis Investigative Site, Sutton

CV2 2DX

Novartis Investigative Site, Coventry

EC1A 7BE

Novartis Investigative Site, London

NW1 2BU

Novartis Investigative Site, London

NW3 2QG

Novartis Investigative Site, London

TS4 3BW

Novartis Investigative Site, Middlesbrough

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY