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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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 / 10Eligibility criteria met

Find a Location

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

2,974 Previous Clinical Trials

1,789,438 Total Patients Enrolled

95 Trials studying Prostate Cancer

29,704 Patients Enrolled for Prostate Cancer

Blue Earth TherapeuticsUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"The clinicaltrial.gov registry reports that this trial is currently not recruiting patients. This medical experiment was published on March 31st 2024 and most recently updated September 27th 2023, but there are presently 1,342 other trials in progress searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial

2024. "NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066437.