BridgeMD
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
EU CTIS ID: 2024-512338-13-00
What this study is testing
-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.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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).
You likely can't join if
- -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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Switzerland; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.