2024-512338-13-00Active, not recruitingPhase 1
A Phase I, open-label, multi-center 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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Sept 2026
Brief summary (registry, in English)
-To assess organ dosimetry of AAA617 following the administration of 7.4 GBq (±10%) for up to 12 cycles in taxane-naïve participants with progressive PSMA-positive mCRPC with normal kidney function or mild renal impairment. - To assess the safety of AAA617 following the administration of 7.4 GBq (±10%) for up to 12 cycles in taxane-naïve participants with progressive PSMA-positive mCRPC with normal kidney function or mild renal impairment. -To assess the tolerability of AAA617 following the administration of 7.4 GBq (±10%) for up to 12 cycles in taxane-naïve participants with progressive PSMA-positive mCRPC with normal kidney function or mild renal impairment.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- First submitted
- 21 Jun 2024
- Start date
- 11 Nov 2024
- Lead sponsor
- Novartis Pharma AG
- Diseases
- Prostate cancer
- EU CT number
- 2024-512338-13-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 63
- 13 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -Previous treatment with any of the following within 6 months of study enrollment: Strontium‑89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
- -Any previous radioligand therapy.
- -Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant prostate cancer(mCRPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) is allowed if 12 months have elapsed since completion of this therapy in pre-mCRPC setting. Prior treatment with sipuleucel-T is allowed].
- -Any investigational agents within 42 days prior to the day of the first RLT treatment.
Who the study is looking for
- Participants must be adults ≥ 18 years of age.
- -Participants must have an ECOG performance status ≤ 1
- -Participants must have histological confirmation of adenocarcinoma of the prostate.
- -Participants must be PSMA-positive per gallium (68Ga) gozetotide (also referred to as [68Ga]Ga-PSMA-11 or radiolabeled AAA517 and 68 Ga-PSMA-11) positron emission tomographic–computed tomographic (PET/CT) scans at baseline with at least 1 lesion showing intermediate or high uptake level (PSMA expression score 2 or 3 per PROMISE V2 criteria and no lesions meeting the size criteria as defined in the read rules showing PSMA expression scores 0 or 1 as determined by the central reader.
- -Participants must have a castrate level of serum/plasma testosterone (≤50 ng/dL or ≤1.7 nmol/L) either by pharmaceutical or surgical methods.
- -Participants must have progressed only once on prior second generation ARPIs (abiraterone, enzalutamide, darolutamide, or apalutamide).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Aachen AöR | Aachen | Germany | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Active, not recruiting |
| University Hospital Cologne AöR | Cologne | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Active, not recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) | Munich | Germany | Active, not recruiting |
| Rostock University Medical Center | Rostock | Germany | Active, not recruiting |
| Helios Universitaetsklinikum Wuppertal | Wuppertal | Germany | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Active, not recruiting |
| Radboud Universitair Medisch Centrum (Radboudumc) | Nijmegen | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.