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NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

NCT06066437 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-05

No results posted yet for this study

Summary

To learn if the proposed dose of 177Lu rhPSMA-10.1 is safe. Phase 2 will open if the Phase 1 dose is found to be safe.

To learn about the safety and effects of 177Lu rhPSMA-10.1 alone and with androgen deprivation therapy (ADT) on patients with high-risk, localized prostate cancer before they have surgery to remove the disease.

Conditions

Interventions

DRUG

Arm A: 177Lu rhPSMA-10.1

Participants will receive 177Lu rhPSMA-10.1 alone.

DRUG

Arm B: 177Lu rhPSMA-10.1 plus Degarelix

Participants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix

Sponsors & Collaborators

  • Blue Earth Therapeutics

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Brian Chapin, M D · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-29
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06066437 on ClinicalTrials.gov