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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06531499
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • AAA617 — DRUG
    \[177Lu\]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.
  • Gonadotropin-releasing hormone (GnRH) analogues — DRUG
    Anatomical Therapeutic Chemical \[ATC\] code L02AE
  • Gonadotropin-releasing hormone (GnRH) antagonists — DRUG
    Degarelix, Relugolix

Study Details

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

Key Dates

Start date
Nov 11, 2024
Status verified
Dec 2025
Primary completion
Nov 24, 2028
Completion
Nov 24, 2028

Study Design

Enrollment
106 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AAA617
    All participants will receive the investigational product AAA617 (7.4 GBq ±10%).

Primary Outcome Measure

Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs [ Time Frame: From Cycle 1 to Cycle 12; cycle = 42 days ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (5)

FacilityCityStateZIPSite coordinators
University of California LALos AngelesCalifornia90095
Stephanie Lira
[email protected]
Matthew Rettig (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Kavin Tamizhmani
[email protected]
Hong Song (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Noah Uhlenkamp
[email protected]
507-538-2155
Daniel Childs (PRINCIPAL_INVESTIGATOR)
Wash U School of MedicineSt LouisMissouri63110
Jennifer Frye
[email protected]
Vikas Prasad (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer SpecialistsOmahaNebraska68130
Marlene Bridwell
[email protected]
402-691-6972
Samuel Mehr (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California LA· Los Angeles, CAStanford University· Palo Alto, CAMayo Clinic Rochester· Rochester, MNWash U School of Medicine· St Louis, MONebraska Cancer Specialists· Omaha, NE

Related Studies