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
Key facts
- Where
- Aachen, Berlin, Bonn, Cologne, Essen, Munich, Rostock és Wuppertal, NémetországSee the 8 sites
- Phase
- 1. fázis
Where in Németország
- Universitaetsklinikum Aachen AöRAachen, NémetországNo longer taking part
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- Universitaetsklinikum Bonn AöRBonn, NémetországNo longer taking part
- University Hospital Cologne AöRCologne, NémetországNo longer taking part
- Universitaetsklinikum Essen (AoR)Essen, NémetországNo longer taking part
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, NémetországNo longer taking part
- Rostock University Medical CenterRostock, NémetországNo longer taking part
- Helios Universitaetsklinikum WuppertalWuppertal, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2024-512338-13-00
- Record updated
- 2026. szeptember 14.
- Original description
-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.Read full original descriptionShow less
-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.
Inclusion: 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).
Exclusion: -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.