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New treatment option for Prostate Cancer
Official title NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
ClinicalTrials.gov ID: NCT06066437
What this study is testing
What is Arm A: 177Lu rhPSMA-10.1?
Arm A: 177Lu rhPSMA-10.1 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Has no very-high-risk features and has exactly one high-risk feature:
- cT3a
- Grade Group 4 or Grade Group 5
You likely can't join if
- Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-α reductase inhibitors allowed), or...
- Currently enrolled in another treatment study
- Concurrent treatment with systemic corticosteroids (prednisone dose \>10 mg per day or equivalent) or other immunosuppressive drugs \<14 days prior...
- Known evidence of an active infection requiring systemic therapy such as uncontrolled human immunodeficiency virus (HIV), active hepatitis, or fungal...
- 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...
- Patients with HIV must agree to adhere to anti-retroviral therapy for the entirety of their participation in the protocol unless dictated by...
See the full eligibility criteria
Who can 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...
- 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
- 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...
- 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...
- 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)...
- 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 \ 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...
- 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), people must use a condom during sexual activity while on study drug and for 6 months following the last dose of study drug. If the...
What rules you out
- 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 treatment 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.