Prostate CancerPhase 1/2NCT06066437
NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
A Phase 1/2 study testing Arm A: 177Lu rhPSMA-10.1 and Arm B: 177Lu rhPSMA-10.1 plus Degarelix in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Arm A: 177Lu rhPSMA-10.1 and Arm B: 177Lu rhPSMA-10.1 plus Degarelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2024to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 2 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
- ECOG performance status (PS) grade 1
- No evidence of metastatic disease or clinically positive lymph nodes as documented by technetium99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to randomization
- Minimum prostate tumor volume of 1.5 cm3 or greater as measured on prostate MRI within 60 days prior to randomization
- Distant metastatic disease or clinically positive lymph nodes not identified by conventional imaging including by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans but identified PSMA PET is allowed based on provider discretion
- PSMA expression within the primary tumor with a minimum SUVmax of the primary tumor of at least 8
- Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for and plan to undergo radical prostatectomy and pelvic lymph node dissection
- No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy
- Adequate bone marrow function documented by:
- Hemoglobin ≥11 g/dL
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥150 x 109/L
- Adequate renal function defined as creatinine <1.5 x ULN or estimated glomerular filtration rate >60 mL/min/1.73 m2 using BSA with CKD-EPI
- Adequate hepatic function documented by:
- Total bilirubin ≤1.5 x ULN
- AST ≤2.5 x ULN
- ALT ≤2.5 x ULN
- Alkaline Phosphatase (ALP) ≤2.5 x ULN
- Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history
- Consents to providing whole blood samples for correlative PSMA evaluation of circulating tumor cells and extra cellular vesicles
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient
- To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 6 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug.
Who cannot join
- 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.
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- 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
- History of major implant(s) or device(s), including but not limited to:
- Prosthetic heart valve(s)
- Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed
- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤2 years prior to enrollment
- Has received major surgery within 90 days of first administration of study drug
- Prior allogeneic stem cell transplantation or recipients of organ transplants or autologous stem cell transplantation at any time MD Anderson Protocol Number: 2022-0500 2022-0500 Version Date 8/29/2023 26
- Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study
- Previously received external beam irradiation to the pelvis or to a field that includes more than 30% of the bone marrow or kidneys
- Previous treatment with any of the following: PSMA-targeted radionuclide therapy, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
- Transfusion of blood products for the sole purpose of meeting the eligibility criteria for this clinical trial
- Patient has a functionally or anatomically solitary kidney.
- Patients with Hydronephrosis and a Mag3 Lasix Renogram that demonstrates objective urinary obstruction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Marisa Lozano, 713-792-3250, mllozano@mdanderson.org
Brian Chaplin, M D
About this study
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.
Read the detailed description
Primary Objectives:
The primary objective of the study is to assess safety and toxicity of 177Lu rhPSMA-10.1 Injection and to assess the impact of 177Lu rhPSMA-10.1 Injection with and without ADT on radiation dose delivered to the tumor in high risk localized and locoregional prostate cancer prior to primary radical prostatectomy with lymph node dissection.
Secondary Objectives:
- To assess the impact on pathologic outcomes at radical prostatectomy after 2 cycles of 177Lu rhPSMA-10.1 Injection with and without ADT Exploratory Objectives
- To evaluate the IHC expression of PSMA on pre-treatment prostate biopsy specimen compared to post ADT and 177Lu rhPSMA-10.1 Injectiontreatment surgical pathology
- To assess the impact on PSMA PET signal after treatment with 177Lu rhPSMA-10.1 Injection with and without ADT
- To evaluate efficacy of neoadjuvant 177Lu rhPSMA-10.1 Injection with or without ADT in men with high-risk and localized prostate cancer planned to undergo radical prostatectomy
- To evaluate exploratory predictive biomarkers for 177Lu rhPSMA-10.1 Injection with or without ADT including circulating tumor cells and extracellular vesicles
- Conditions
- Prostate Cancer
- Being tested
- Arm A: 177Lu rhPSMA-10.1, Arm B: 177Lu rhPSMA-10.1 plus Degarelix
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm A: 177Lu rhPSMA-10.1Drug
Participants will receive 177Lu rhPSMA-10.1 alone.
Arm B: 177Lu rhPSMA-10.1 plus DegarelixDrug
Participants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix
| Study group | Role | What they receive |
|---|---|---|
| LeadIn: Treatment with 177Lu rhPSMA-10.1 | Experimental | Participants will receive 177Lu rhPSMA-10.1 alone. Receives: Drug: Arm A: 177Lu rhPSMA-10.1; Drug: Arm B: 177Lu rhPSMA-10.1 plus Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average 1 year
Efficacy will be assess by measuring the radiation dose to the tumor (dosimetries) and PSA assessment
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start29 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Therapeutics Ltd
- Responsible party
- Sponsor
- Investigators
- Brian Chapin, M D, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066437
- Sponsor's protocol ID
- 2022-0500
- Other IDs
- NCI-2023-08252
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
- ClinicalTrials.gov ID
- NCT06066437
- Acronym / sponsor ID
- 2022-0500
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Blue Earth Therapeutics Ltd
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
The primary objective of the study is to assess safety and toxicity of 177Lu rhPSMA-10.1 Injection and to assess the impact of 177Lu rhPSMA-10.1 Injection with and without ADT on radiation dose delivered to the tumor in high risk localized and locoregional prostate cancer prior to primary radical prostatectomy with lymph node dissection.
Secondary Objectives:
- To assess the impact on pathologic outcomes at radical prostatectomy after 2 cycles of 177Lu rhPSMA-10.1 Injection with and without ADT Exploratory Objectives
- To evaluate the IHC expression of PSMA on pre-treatment prostate biopsy specimen compared to post ADT and 177Lu rhPSMA-10.1 Injectiontreatment surgical pathology
- To assess the impact on PSMA PET signal after treatment with 177Lu rhPSMA-10.1 Injection with and without ADT
- To evaluate efficacy of neoadjuvant 177Lu rhPSMA-10.1 Injection with or without ADT in men with high-risk and localized prostate cancer planned to undergo radical prostatectomy
- To evaluate exploratory predictive biomarkers for 177Lu rhPSMA-10.1 Injection with or without ADT including circulating tumor cells and extracellular vesicles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LeadIn: Treatment with 177Lu rhPSMA-10.1 | Experimental | Drug: Arm A: 177Lu rhPSMA-10.1, Drug: Arm B: 177Lu rhPSMA-10.1 plus DegarelixParticipants will receive 177Lu rhPSMA-10.1 alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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).
- 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
- ECOG performance status (PS) grade 1
Key exclusion criteria (27 listed)
- 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.
- History of clinically significant cardiovascular disease including, but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm A: 177Lu rhPSMA-10.1Participants will receive 177Lu rhPSMA-10.1 alone. | Drug | LeadIn: Treatment with 177Lu rhPSMA-10.1 |
| Arm B: 177Lu rhPSMA-10.1 plus DegarelixParticipants will receive 177Lu rhPSMA-10.1 alone. Participants will receive 177Lu rhPSMA-10.1 with Degarelix | Drug | LeadIn: Treatment with 177Lu rhPSMA-10.1 |
Primary outcome
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
Efficacy will be assess by measuring the radiation dose to the tumor (dosimetries) and PSA assessment
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Chapin, M D principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Arm A: 177Lu rhPSMA-10.1 and Arm B: 177Lu rhPSMA-10.1 plus Degarelix in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Chapin, MD ((713) 792-3250, bfchapin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.