Could custom doses of prostate cancer radiation be safer and stronger?
NCT ID NCT06943495
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether giving a personalized dose of the drug 177Lu-PSMA-617 (Pluvicto) based on kidney function is safer and allows higher doses than the standard fixed dose. Sixty men with metastatic castration-resistant prostate cancer will receive either personalized or fixed doses over six cycles. The goal is to see if personalization can safely increase the amount of radiation delivered.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto)
- What this could lead to
- If successful, this could show that tailoring radiation doses to each patient improves safety and effectiveness for treating advanced prostate cancer.
- What could go wrong
- This is a small early-phase pilot study, so results may not apply broadly. There are risks of serious side effects like low blood counts or kidney damage.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2033
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: 1. Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma; 2. Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy; 3. Progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of 1-week intervals, with serum testosterone level ≤ 1.7 nmol/dL); 4. PSA ≥2 ng/mL ; 5. Prior treatment with at least one ARPI; 6. PSMA-expressing cancer, with significant PSMA expression defined as SUVpeak in at least one lesion that is superior to SUVmean of the liver on PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL), within 45 days prior to randomization; 7. ECOG Performance status 0 to 2; 8. Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m\^2; 9. Albumin ≥ 25 g/L; 10. Platelets ≥ 100x10\^9/L; 11. Neutrophils ≥ 1.5x10\^9/L; 12. Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks; 13. Signed, written informed consent Exclusion Criteria: 1. PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement); 2. Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization; 3. Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (adjuvant and neoadjuvant chemotherapy does not count) towards the maximum of two regimens); 4. Prior radiopharmaceutical therapy; 5. Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment; 6. Active malignancy other than prostate cancer; 7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception; 8. Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct; 9. Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
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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
1 site. 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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CHU de Québec-Université Laval
RECRUITINGQuébec, Quebec, G1R2J6, Canada
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