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 ID: NCT06531499
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
106 participants
INTERVENTIONAL
2024-11-11
2028-11-24
Brief Summary
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Detailed Description
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Screening Period: Approximately 106 participants will be enrolled to receive up to12 consecutive cycles of AAA617. Potential participants will be assessed for eligibility by verifying their baseline PSMA PET scan for mandatory confirmation of PSMA positivity prior to first cycle by local review.
Treatment Period: Eligible participants will be treated with up to 12 cycles of 7.4 GBq AAA617 intravenously every 6 weeks, until radiographic progression, toxicity leading to treatment discontinuation, death, loss to follow-up, or withdrawal of consent, whichever occurs first. During treatment period, all participants who complete the initial 6 cycles of AAA617 treatment will undergo an additional PSMA-PET scan after Cycle 6 to re-assess PSMA expression level and to reassess eligibility of participants to receive additional AAA617 treatment cycles.
Post-Treatment Follow-Up: All participants will undergo a PSMA-PET scan at end of treatment (EOT). The post-treatment follow-up period will consist of EOT; 42-days safety; EOT RLI; safety, survival and rPFS follow-up visits.
The planned duration of treatment period is up to 74 weeks with treatment given every 6 weeks. Participants may be discontinued from treatment earlier due to unacceptable toxicity or disease progression, and/or at the discretion of the Investigator or the participant.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AAA617
All participants will receive the investigational product AAA617 (7.4 GBq ±10%).
AAA617
\[177Lu\]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.
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
Gonadotropin-releasing hormone (GnRH) antagonists
Degarelix, Relugolix
Interventions
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AAA617
\[177Lu\]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.
Gonadotropin-releasing hormone (GnRH) analogues
Anatomical Therapeutic Chemical \[ATC\] code L02AE
Gonadotropin-releasing hormone (GnRH) antagonists
Degarelix, Relugolix
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 68Ga-PSMA PET/CT scans at baseline
* 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
* Documented progressive mCRPC
* Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening/baseline CT, MRI, or bone scan
* Renal: eGFR ≥ 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
* Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia.
Exclusion Criteria
* Any previous radioligand therapy.
* Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \[including monoclonal antibodies\]. \[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\].
* Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy
* History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
* Concurrent serious acute or chronic nephropathy and/or moderate to severe renal impairment as determined by the principal investigator.
* Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment
* Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment.
* Concurrent urinary outflow obstruction or unmanageable urinary incontinence
* History of somatic or psychiatric disease/condition that may interfere with the aims and assessments of the study.
18 Years
100 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Stanford University
Palo Alto, California, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Wash U School of Medicine
St Louis, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany
Novartis Investigative Site
Aachen, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Rostock, , Germany
Novartis Investigative Site
Nijmegen, Gelderland, Netherlands
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
Majadahonda, Madrid, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Bern, , Switzerland
Novartis Investigative Site
Sutton, Surrey, United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Tiffany Chen
Role: primary
Carrie Hruska
Role: primary
Wilton Lyons
Role: primary
Jena Depue
Role: primary
Other Identifiers
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2024-512338-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAAA617A12101
Identifier Type: -
Identifier Source: org_study_id