Trial · 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

NCT06531499, Phase 1, Active not recruiting, Novartis Pharmaceuticals

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT06531499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06531499

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT06531499
Status: Active not recruiting
Phases: Phase 1
Enrollment: 110 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Metastatic Castration-Resistant Prostate Cancer
Interventions: AAA617, Gonadotropin-releasing hormone (GnRH) analogues, Gonadotropin-releasing hormone (GnRH) antagonists
First posted: 2024-08-01
Last updated: 2026-10-20

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs	From Cycle 1 to Cycle 12; cycle = 42 days	Time activity curve (TAC) will be generated from the amount radioactivity in one given tissue. Time integrated activity coefficient and absorbed dose will be calculated
Primary	Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)	For up to 12 cycles in taxane-naive participants with progressive PSMA-positive mCRPC with nrmal kidney function or mild renal impairment; cycle = 42 days	The distribution of adverse events for Radioligand Therapy (RLT) will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters. Adverse event monitoring should be continued for at least 42 days following the end of treatment (EOT) visit. Participants receiving the study treatment will continue to be followed for safety every 12 weeks during the long-term follow-up for selected adverse events
Primary	Percentage of participants with AAA617 dose reductions, interruptions and discontinuations	Up to 42 (+7) days after last AAA617 dose administration (Safety Follow-up)	The assessment of tolerability will be based on the frequency of participants with dose interruptions, reductions, and study treatment discontinuations. Dose reduction will be based on the worst toxicity demonstrated at the last dose.
Secondary	Time activity curves (TACs) and absorbed radiation dose AAA617 in tumors	For up to 12 cycles; cycle = 42 days	Time activity curves (TACs) will be generated from the amount of radioactivity in one given tissue at a given moment. TACs will be fitted to mono- and bi-exponential curves. Time integrated activity coefficient and absorbed dose will be calculated.
Secondary	Pharmacokinetic ( PK) concentration of AAA617 in blood over time	Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12, cycle = 42 days	PK concentrations will be listed by patient and visit/sampling time point. The descriptive summary statistics will be provided by visit/sampling time point.
Secondary	Pharmacokinetic (PK) parameter Cmax of AAA617 from blood radioactivity data	Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days	Derived PK parameter, Cmax will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Cmax is the maximum drug concentration after dosing.
Secondary	PK parameter Tmax of AAA617 from blood radioactivity data	Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days	Derived PK parameter Tmax, will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Tmax is the time to reach the maximum concentration.
Secondary	PK parameter AUC of AAA617 from blood radioactivity data	Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days	Derived PK parameter AUC will be listed by patient and visit. The descriptive summary statistics will be provided by visit. AUC: Area under the concentration-time curve.
Secondary	PK parameter CL of AAA617 from blood radioactivity data	Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days	Derived PK parameter CL will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Clearance (CL): Rate at which the body eliminates the drug.
Secondary	PK parameter VZ of AAA617 from blood radioactivity data	Cycle 1, Cycle 4, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11 and Cycle 12; cycle = 42 days	Derived PK parameter Vz will be listed by patient and visit. The descriptive summary statistics will be provided by visit. Vz: volume of distribution during the terminal phase (Vz).

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06531499

GET https://conductscience.org/api/trials/v1/NCT06531499/registered

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