NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

NCT06066437 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-0500NCI-2023-08252
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average 1 year

• Efficacy will be assess by measuring the radiation dose to the tumor (dosimetries) and PSA assessment

  Up to 6 months

Study Arms (1)

LeadIn: Treatment with 177Lu rhPSMA-10.1

EXPERIMENTAL

Participants will receive 177Lu rhPSMA-10.1 alone.

Drug: Arm A: 177Lu rhPSMA-10.1; Drug: Arm B: 177Lu rhPSMA-10.1 plus Degarelix

Interventions

Arm A: 177Lu rhPSMA-10.1 DRUG

Participants will receive 177Lu rhPSMA-10.1 alone.

LeadIn: Treatment with 177Lu rhPSMA-10.1

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

LeadIn: Treatment with 177Lu rhPSMA-10.1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ≥18 years of age
• Histologically documented prostatic adenocarcinoma with an NCCN risk group of high-risk or very high-risk. NCCN High Risk and Very High-Risk criteria shown below. (Network, N.C.C. (2021).
• Prostate Cancer (Version 02.2021).
• High Risk:
• Has no very-high-risk features and has exactly one high-risk feature:
• cT3a
• Grade Group 4 or Grade Group 5
• PSA \>20 ng/mL
• Very high:
• Has at least one of the following:
• cT3b-cT4
• Primary Gleason pattern 5
• or 3 high-risk features
• \>4 cores with Grade Group 4 or 5
• Prostate biopsy within 90 days prior to randomization is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible

You may not qualify if:

• Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-α reductase inhibitors allowed), or LHRH agonists/antagonists
• Currently enrolled in another interventional study
• Concurrent treatment with systemic corticosteroids (prednisone dose \>10 mg per day or equivalent) or other immunosuppressive drugs \<14 days prior to treatment initiation Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted.
• Known evidence of an active infection requiring systemic therapy such as uncontrolled human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Uncomplicated urinary tract infection (UTI) does not qualify as an excluding infection.
• Patients with HIV must be on an effective anti-retroviral regimen atleast four weeks prior to enrollment, HIV viral load less than 400 copies/mL and CD4+ T cell counts greater than 350 cell/uL.
• Patients with HIV must agree to adhere to anti-retroviral therapy for the entirety of their participation in the protocol unless dictated by treatment toxicities.
• Patients on Tenofovir will be excluded as there is a known risk of proximal renal tubule dysfunction leading to renal toxicity. Given that PSMA is expressed on the proximal tubule there is a theoretical risk of overlapping toxicity.
• History of clinically significant cardiovascular disease including, but not limited to:
• Myocardial infarction or unstable angina ≤6 months prior to treatment initiation
• Clinically significant cardiac arrhythmia
• Deep vein thrombosis, pulmonary embolism, stroke ≤6 months prior to treatment initiation
• Congestive heart failure (New York Heart Association class III-IV)
• Pericarditis/clinically significant pericardial effusion
• Myocarditis
• Endocarditis

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Blue Earth Therapeutics: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Brian Chapin, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Chapin, MD

CONTACT

(713) 792-3250; bfchapin@mdanderson.org

Marisa Lozano

CONTACT

(713) 792-3250; mllozano@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: March 29, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)