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

Study acronym: RADIODOSE
StatusActive, Not Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Nov 24, 2028 → Apr 24, 2029
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Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary and study completion pushed from Nov 24, 2028 to Apr 24, 2029
    • Enrollment target: estimated 106 to confirmed 110
    • Study sites: 21 to 22
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 11 of 15 entries
  2. Study sites: 17 to 21v14
  3. Study sites: 16 to 17v13
  4. Study sites: 15 to 16v12
  5. Study sites: 13 to 15v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 12 to 13v10
  2. Primary completion date: Dec 27, 2027 to Nov 24, 2028
    • Study sites: 8 to 12
    • Study completion date: Feb 9, 2028 to Nov 24, 2028
    v9
  3. Study sites: 7 to 8v8
  4. Study sites: 6 to 7
    • Primary completion date: Dec 3, 2027 to Dec 27, 2027
    • Study completion date: Jan 18, 2028 to Feb 9, 2028
    v7
  5. Primary completion date: Dec 27, 2027 to Dec 3, 2027
    • Study completion date: Feb 9, 2028 to Jan 18, 2028
    • Site contacts updated at 1 of 6 sites
    v6
  6. Study sites: 5 to 6
    • Primary completion date: Dec 8, 2027 to Dec 27, 2027
    • Study completion date: Jan 21, 2028 to Feb 9, 2028
    v5
  7. Study sites: 4 to 5v4
  8. Study sites: 3 to 4v3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Oct 30, 2024 to Nov 11, 2024
    • Secondary endpoints: details revised at 7 of 15 entries
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
556 trials monitored
See 33 trials at risk
Prostate Cancer
2,555 trials monitored
See 170 trials at risk
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).
Trial Details
NCT Number NCT06531499
Lead Sponsor Novartis Pharmaceuticals
Conditions
(from sponsor)		 Metastatic Castration-Resistant Prostate Cancer
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov