NCT06531499 - A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study | Biotech Hunter

Enrollment

106

Participants

Timeline

Start Date

November 11, 2024

Primary Completion Date

November 24, 2028

Study Completion Date

November 24, 2028

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

DRUG

AAA617

\[177Lu\]Lu-PSMA-617 will be administered as an intravenous infusion at a dose of 7.4 GBq (200mCi) (+/- 10%), every 6 weeks for up to 12 cycles.

DRUG

Gonadotropin-releasing hormone (GnRH) analogues

Anatomical Therapeutic Chemical \[ATC\] code L02AE

DRUG

Gonadotropin-releasing hormone (GnRH) antagonists

Degarelix, Relugolix

Trial Locations (15)

3010

RECRUITING

Novartis Investigative Site, Bern

15706

RECRUITING

Novartis Investigative Site, Santiago de Compostela

18057

RECRUITING

Novartis Investigative Site, Rostock

28222

RECRUITING

Novartis Investigative Site, Madrid

45147

RECRUITING

Novartis Investigative Site, Essen

50937

RECRUITING

Novartis Investigative Site, Cologne

55905

RECRUITING

Mayo Clinic Rochester, Rochester

63110

RECRUITING

Wash U School of Medicine, St Louis

68130

RECRUITING

Nebraska Cancer Specialists, Omaha

80377

RECRUITING

Novartis Investigative Site, München

94304

RECRUITING

Stanford University, Palo Alto

6500HB

RECRUITING

Novartis Investigative Site, Nijmegen

08041

RECRUITING

Novartis Investigative Site, Barcelona

SM2 5PT

RECRUITING

Novartis Investigative Site, Sutton

B15 2TH

RECRUITING

Novartis Investigative Site, Birmingham