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177Lu rhPSMA-10.1 +/- Hormone Therapy for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Brian Chapin, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men ≥18 years of age

Histologically documented prostatic adenocarcinoma with an NCCN risk group of high-risk or very high-risk

Must not have

Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-α reductase inhibitors allowed), or LHRH agonists/antagonists

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial will assess the safety of a drug (177Lu rhPSMA-10.1) to treat high-risk prostate cancer before surgery, with and without hormone therapy.

Who is the study for?

Men over 18 with high-risk, localized prostate cancer who haven't had previous treatments and are candidates for surgery. They must have a certain tumor size on MRI, no metastatic disease or positive lymph nodes (unless allowed by the doctor), good liver and kidney function, adequate bone marrow function, and agree to use condoms during sexual activity.

What is being tested?

The Nautilus Trial is testing the safety of a drug called 177Lu rhPSMA-10.1 alone (Arm A) and combined with hormone therapy Degarelix (Arm B) in men before they undergo surgery for high-risk prostate cancer. The trial will proceed to Phase 2 if Phase 1 shows that the dose is safe.

What are the potential side effects?

Possible side effects include reactions related to radiation exposure such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, potential kidney issues due to PSMA expression in renal tubules, and hormonal side effects from Degarelix.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

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My prostate cancer is classified as high-risk or very high-risk.

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My cancer is not small cell, neuroendocrine, or transitional cell carcinoma.

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I can do light work but not heavy physical activities.

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My primary tumor shows high PSMA expression.

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My kidney function is within the normal range.

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My liver tests are within normal limits.

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My prostate tumor is larger than 1.5 cm3 as confirmed by a recent MRI.

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My prostate cancer is at a stage where surgery to remove it is possible.

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I have not received any treatment for prostate cancer, except possibly TURP.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received hormone therapy for prostate cancer.

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I am not currently taking Tenofovir.

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I have had a stem cell or organ transplant.

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I've had radiation therapy to my pelvis or an area affecting a lot of my bone marrow or kidneys.

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I have not received blood products just to qualify for this trial.

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I have only one working kidney.

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I have HIV, am on effective treatment, and my viral load is low.

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I have previously received specific radioactive treatments for cancer.

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I have had serious heart problems or blood clots in the last 6 months.

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I have swelling of a kidney due to urine buildup and a test showing blocked urine flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups

Experimental Treatment

Group I: LeadIn: Treatment with 177Lu rhPSMA-10.1Experimental Treatment2 Interventions

Participants will receive 177Lu rhPSMA-10.1 alone.

0 / 20Eligibility criteria met

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Who is running the clinical trial?

AVEO Pharmaceuticals, Inc.Industry Sponsor

45 Previous Clinical Trials

3,914 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,665 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,621 Patients Enrolled for Prostate Cancer

Blue Earth TherapeuticsUNKNOWN

~22 spots leftby Jun 2025

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