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

Phase 1

• Conditions: Metastatic neuroendocrine prostate cancer; Cancer

• Registration Number: ISRCTN40970912
• Lead Sponsor: ovartis Pharmaceuticals UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-04
• Last Update Posted: 9 September 2024
• Study Completion: 2027-11-12

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 106

Inclusion Criteria

1.Participants must be adults =18 years of age.
2.Participants must have an ECOG performance status =1
3.Participants must have histological confirmation of adenocarcinoma of the prostate
4.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
5.Participants must have a castrate level of serum/plasma testosterone (=50 ng/dL or =1.7 nmol/L) either by pharmaceutical or surgical methods
6.Participants must have progressed only once on prior second generation ARPIs (abiraterone, enzalutamide, darolutamide, or apalutamide)

Exclusion Criteria

1.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.
2.Any previous radioligand therapy.
3.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].
4.Any investigational agents within 42 days prior to the day of the first RLT treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified