Radioactive drug aims to shrink aggressive prostate tumors before surgery
NCT ID NCT06798558
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial is testing whether a single dose of Lu-177-PSMA-617 (Pluvicto), a radioactive drug that targets prostate cancer cells, can shrink or eliminate high-risk prostate tumors before surgery. About 54 men with aggressive prostate cancer (Gleason score 8 or higher) will receive the drug and then undergo prostatectomy. The main goal is to see if the cancer is less advanced after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lu-177-PSMA-617 (Pluvicto), a radioactive drug that targets prostate cancer cells
- What this could lead to
- If successful, this could offer a new way to shrink aggressive prostate tumors before surgery, potentially reducing the risk of cancer returning.
- What could go wrong
- This is a small, early-phase trial with only 54 participants, so results may not apply to all patients. The drug is radioactive and may cause side effects like dry mouth, fatigue, or blood cell changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients age 18 or older. * Patients with histologically confirmed adenocarcinoma of the prostate. * Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 \[GG4\]) or higher. Men with evidence of lymph node involvement at or below the bifurcation of the common iliac arteries (cN1) on PET-CT 68Ga-PSMA-11 are eligible. * Pre-operative, pre-treatment PSMA scan with high expression in prostate confirmed by PET/CT 68Ga-PSMA-11 (greater than liver). Patients must not have any other PET FDG-positive sites outside the prostate. * Patients who are able and willing to undergo surgery. * Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using any 1 of the following tools: * The Social Security Administration tables: https://www.ssa.gov/OACT/STATS/table4c6.html * The WHO's Life Tables by country: https://apps.who.int/gho/data/view.main.60000?lang=en * The Memorial Sloan Kettering Male Life Expectancy tool: https://www.mskcc.org/nomograms/prostate * If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information. * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below: * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 14 weeks after the final dose of study treatment. Men must refrain from donating sperm during this same period. * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 14 weeks after the final dose of study treatment to avoid potential exposure to the embryo. * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception. * Patients who are able to comply with follow-up visits and treatment plans. * Patients who are able to give informed consent. Exclusion Criteria: * Patients with a prior history of prostate cancer treatment. * Patients with previous treatment with PSMA-targeted radioligand therapy or any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation. * Patients with distant disease (outside of local lymph nodes). * Significant bone marrow impairment defined by leukocytes \<3,000/mcL, absolute neutrophil count (ANC) \<1,500/mcL, and platelet count lower than 70,000/mcL. * Significant liver function impairment defined by total bilirubin higher than 1.5 times the upper limit of normal (ULN), andASL/ALT higher than 3 times the ULN. * Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min, or concomitant use of nephrotoxic drugs. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation: * Normal renal function: participants with eGFR 90 mL/min * Moderate renal impairment: participants with eGFR 30 to 59 mL/min * Severe renal impairment: participants with eGFR 15 to 29 mL/min * Patients with significant comorbidities that would make them poor candidates for surgery. * Patients with evidence of metastatic disease (enlarged lymph nodes, distant metastatic sites, visceral or bone metastases, etc.). * Patients with a history of radiation or hormone therapy to the prostate. * Patients with a history of bleeding disorders or who are taking anticoagulant therapy. * Patients with active infections or other contraindications for surgery. * Patients who are unable or unwilling to give informed consent. * Patients who are unable to comply with follow-up visits and treatment plans
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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John Theurer Cancer Center at Hackensack University Medical Center
RECRUITINGHackensack, New Jersey, 07601, United States
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Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
NOT_YET_RECRUITINGWashington D.C., District of Columbia, 20057, United States
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MedStar Washington Hospital Center
NOT_YET_RECRUITINGWashington D.C., District of Columbia, 20010, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?