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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Novartis Pharmaceuticals +41613241111


Novartis Pharmaceuticals 1-888-669-6682
novartis.email@novartis.com


Study Location:

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English | Cymraeg
Be Part of Research - Trial Details - A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naĂŻve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

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

Recruiting

Open to: MALE

Age: 18.0 - 100.0

Medical Conditions

Prostatic Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2024 Dec 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : \[177Lu\]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.

Intervention Arm Group : AAA617;

Intervention Type : DRUG
Intervention Description : Anatomical Therapeutic Chemical \[ATC\] code L02AE

Intervention Arm Group : AAA617;

Intervention Type : DRUG
Intervention Description : Degarelix, Relugolix

Intervention Arm Group : AAA617;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Novartis Investigative Site
    Sutton
    Surrey
    SM2 5PT

Novartis Pharmaceuticals 1-888-669-6682
novartis.email@novartis.com


Novartis Pharmaceuticals +41613241111



The study is sponsored by Novartis Pharmaceuticals





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Read full details for Trial ID: NCT06531499
Last updated 17 April 2025

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