NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06066437
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Arm A: 177Lu rhPSMA-10.1 — DRUG
    Participants will receive 177Lu rhPSMA-10.1 alone.
  • Arm B: 177Lu rhPSMA-10.1 plus Degarelix — DRUG
    Participants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix

Study Details

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.

Key Dates

First listed
Oct 4, 2023
Start date
Mar 29, 2024
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LeadIn: Treatment with 177Lu rhPSMA-10.1
    Participants will receive 177Lu rhPSMA-10.1 alone.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Marisa Lozano
[email protected]
713-792-3250
Brian Chaplin, M D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
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By research site
M D Anderson Cancer Center· Houston, TX

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