Status:
RECRUITING
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Castration-Resistant Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE1
Brief Summary
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-PSM...
Detailed Description
The study includes screening period, treatment period, and a post-treatment follow-up period. Screening Period: Approximately 106 participants will be enrolled to receive up to12 consecutive cycles o...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study.
- 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
- 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 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 24 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06531499
Start Date
November 11 2024
End Date
November 24 2028
Last Update
December 31 2025
Active Locations (21)
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1
University of California LA
Los Angeles, California, United States, 90095
2
Stanford University
Palo Alto, California, United States, 94304
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
4
Wash U School of Medicine
St Louis, Missouri, United States, 63110