An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

March 12, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

October 3, 2031

Conditions
Oligometastatic Prostate Cancer (OMPC)
Interventions
DRUG

AAA617

Stereotactic Body Radiation Therapy (SBRT) followed by AAA617 will be administered once every 6 weeks (1 cycle) for a planned 4 cycles to participants randomized to the Investigational arm

Trial Locations (130)

1090

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Vienna

1211

RECRUITING

Novartis Investigative Site, Geneva

2010

RECRUITING

Novartis Investigative Site, Darlinghurst

2610

RECRUITING

Novartis Investigative Site, Wilrijk

3144

RECRUITING

Novartis Investigative Site, Malvern

4020

ACTIVE_NOT_RECRUITING

Novartis Investigative Site, Linz

4029

RECRUITING

Novartis Investigative Site, Herston

4032

RECRUITING

Novartis Investigative Site, Debrecen

5000

RECRUITING

Novartis Investigative Site, Adelaide

6006

RECRUITING

Novartis Investigative Site, Lucerne

8063

RECRUITING

Novartis Investigative Site, Zurich

9000

RECRUITING

Novartis Investigative Site, Ghent

9300

RECRUITING

Novartis Investigative Site, Aalst

10002

RECRUITING

Novartis Investigative Site, Taipei

10065

RECRUITING

Memorial Sloane Ketterin Cancer Ctr, New York

10249

RECRUITING

Novartis Investigative Site, Berlin

11217

RECRUITING

Novartis Investigative Site, Taipei

13210

RECRUITING

Associated Med Professionals of NY, Syracuse

16132

RECRUITING

Novartis Investigative Site, Genova

18014

RECRUITING

Novartis Investigative Site, Granada

18057

RECRUITING

Novartis Investigative Site, Rostock

20089

RECRUITING

Novartis Investigative Site, Rozzano

20141

RECRUITING

Novartis Investigative Site, Milan

21201

RECRUITING

University of Maryland Medical Ctr, Baltimore

21231

RECRUITING

Johns Hopkins Kimmel Com Cancer Ctr, Baltimore

23502

RECRUITING

Virginia Oncology Associates, Norfolk

24382

RECRUITING

Blue Ridge Cancer Center, Wytheville

25123

RECRUITING

Novartis Investigative Site, Brescia

27858

RECRUITING

East Carolina University, Greenville

28040

RECRUITING

Novartis Investigative Site, Madrid

28041

RECRUITING

Novartis Investigative Site, Madrid

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

30120

RECRUITING

Novartis Investigative Site, El Palmar

30318

RECRUITING

Piedmont Healthcare, Atlanta

32256

RECRUITING

Cancer Specialists of North Florida, Jacksonville

32503

RECRUITING

Woodlands Medical Specialists, Pensacola

33076

RECRUITING

Novartis Investigative Site, Bordeaux

33305

RECRUITING

Novartis Investigative Site, Taoyuan District

37024

RECRUITING

Novartis Investigative Site, Negrar

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

41013

RECRUITING

Novartis Investigative Site, Seville

44124

RECRUITING

Novartis Investigative Site, Cona

44805

RECRUITING

Novartis Investigative Site, Saint-Herblain

45147

RECRUITING

Novartis Investigative Site, Essen

45409

RECRUITING

Dayton Physicians, Kettering

46010

RECRUITING

Novartis Investigative Site, Valencia

46050

RECRUITING

Novartis Investigative Site, Petaling Jaya

48073

RECRUITING

Profound Research LLC, Royal Oak

49503

RECRUITING

BAMF Health, Grand Rapids

50937

RECRUITING

Novartis Investigative Site, Cologne

52074

RECRUITING

Novartis Investigative Site, Aachen

55905

RECRUITING

Mayo Clinic Rochester, Rochester

56126

RECRUITING

Novartis Investigative Site, Pisa

59100

RECRUITING

Novartis Investigative Site, Kuala Lumpur

60007

RECRUITING

The Cancer Institute of Alexian Brothers, Elk Grove

60637

RECRUITING

University of Chicago, Chicago

63011

RECRUITING

Novartis Investigative Site, Clermont-Ferrand

63106

RECRUITING

VA St Louis Health Care System, St Louis

63110

RECRUITING

Wash U School of Medicine, St Louis

66160

RECRUITING

University of Kansas Hospital, Kansas City

68114

RECRUITING

Adult and Pedi Urology and Urogyne, Omaha

69677

RECRUITING

Novartis Investigative Site, Bron

70809

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

72703

RECRUITING

Highlands Oncology Group, Fayetteville

76038

RECRUITING

Novartis Investigative Site, Rouen

79912

RECRUITING

Rio Grande Urology, El Paso

80218

RECRUITING

Rocky Mountain Cancer Centers, Denver

83310

RECRUITING

Novartis Investigative Site, Bratislava

86179

RECRUITING

Novartis Investigative Site, Augsburg

90073

RECRUITING

VA Greater LA Healthcare System, Los Angeles

92210

RECRUITING

Novartis Investigative Site, Saint-Cloud

94115

RECRUITING

UCSF, San Francisco

94304

RECRUITING

Stanford University, Palo Alto

97477

RECRUITING

Oregon Urology Institute, Springfield

100036

RECRUITING

Novartis Investigative Site, Beijing

103616

RECRUITING

Novartis Investigative Site, Taipei

119228

RECRUITING

Novartis Investigative Site, Singapore

168583

RECRUITING

Novartis Investigative Site, Singapore

200127

RECRUITING

Novartis Investigative Site, Shanghai

510060

RECRUITING

Novartis Investigative Site, Guangzhou

3109601

RECRUITING

Novartis Investigative Site, Haifa

4941492

RECRUITING

Novartis Investigative Site, Petah Tikva

6423906

RECRUITING

Novartis Investigative Site, Tel Aviv

8457108

RECRUITING

Novartis Investigative Site, Beersheba

9112001

RECRUITING

Novartis Investigative Site, Jerusalem

94304-1207

RECRUITING

VA Palo Alto Health Care System, Palo Alto

02115

RECRUITING

Dana Farber Cancer Institute, Boston

10467 2490

RECRUITING

Montefiore Hospital, The Bronx

75390-9034

RECRUITING

Univ of Texas Southwest Med Center, Dallas

C1181ACH

RECRUITING

Novartis Investigative Site, CABA

C1426ANZ

RECRUITING

Novartis Investigative Site, CABA

C1431FWO

RECRUITING

Novartis Investigative Site, Caba

01246 000

RECRUITING

Novartis Investigative Site, São Paulo

T2N 5G2

RECRUITING

Novartis Investigative Site, Calgary

B3H 2Y9

RECRUITING

Novartis Investigative Site, Halifax

N6A 4G5

RECRUITING

Novartis Investigative Site, London

K1H 8L6

RECRUITING

Novartis Investigative Site, Ottawa

M5G 2M9

RECRUITING

Novartis Investigative Site, Toronto

H2X 1R9

RECRUITING

Novartis Investigative Site, Montreal

H3T 1E2

RECRUITING

Novartis Investigative Site, Montreal

G1J 1Z4

RECRUITING

Novartis Investigative Site, Québec

708 52

RECRUITING

Novartis Investigative Site, Ostrava

779 00

RECRUITING

Novartis Investigative Site, Olomouc

150 06

RECRUITING

Novartis Investigative Site, Prague

540 07

RECRUITING

Novartis Investigative Site, Thessaloniki

H 1122

RECRUITING

Novartis Investigative Site, Budapest

H-1083

RECRUITING

Novartis Investigative Site, Budapest

00168

RECRUITING

Novartis Investigative Site, Roma

277 8577

RECRUITING

Novartis Investigative Site, Kashiwa

812-8582

RECRUITING

Novartis Investigative Site, Fukuoka

960 1295

RECRUITING

Novartis Investigative Site, Fukushima

060 8648

RECRUITING

Novartis Investigative Site, Sapporo

650-0047

RECRUITING

Novartis Investigative Site, Kobe

920 8641

RECRUITING

Novartis Investigative Site, Kanazawa

236-0004

RECRUITING

Novartis Investigative Site, Yokohama

104 0045

RECRUITING

Novartis Investigative Site, Chuo Ku

811-0213

RECRUITING

Novartis Investigative Site, Fukuoka

812-0033

RECRUITING

Novartis Investigative Site, Fukuoka

606 8507

RECRUITING

Novartis Investigative Site, Kyoto

1066 CX

RECRUITING

Novartis Investigative Site, Amsterdam

00921

RECRUITING

VA Caribbean Healthcare System, San Juan

949 01

RECRUITING

Novartis Investigative Site, Nitra

911 01

RECRUITING

Novartis Investigative Site, Trenčín

08025

RECRUITING

Novartis Investigative Site, Barcelona

08036

RECRUITING

Novartis Investigative Site, Barcelona

BS2 8ED

RECRUITING

Novartis Investigative Site, Bristol

GU2 7XX

RECRUITING

Novartis Investigative Site, Guildford

SM2 5PT

RECRUITING

Novartis Investigative Site, Sutton

CV2 2DX

RECRUITING

Novartis Investigative Site, Coventry

NW3 2QG

RECRUITING

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY