Metastatic Castrate Resistant Prostate Cancer study: 177Lu-PSMA-617
Official title Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)
ClinicalTrials.gov ID: NCT06943495
What this study is testing
What is 177Lu-PSMA-617?
an investigational radioligand therapy being studied for metastatic castrate‑resistant prostate cancer (mCRPC). is designed to bind to PSMA on prostate cancer cells and deliver targeted radiation to kill those cells.
Also referred to as Lutetium Lu 177 vipivotide tetraxetan, Pluvicto.
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 see if a personalized dosing schedule is feasible and safe, and whether the radiation dose can be increased without extra harm. It also tracks specific side effects.
- Who it's for
- Men who have metastatic castration‑resistant prostate cancer.
- What's involved
- You will receive up to six injections of Lutetium‑177 PSMA‑617 every six weeks, plus regular imaging scans, lab tests and questionnaires about your health.
- Time commitment
- The study runs for about 30 weeks, with clinic visits every six weeks for treatment and follow‑up tests.
- Phase 1: an early, usually small safety study
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, men only
You may be able to join if
- Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
- Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy...
- Biochemically progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of...
- PSA ≥2 ng/mL ;
- Prior treatment with at least one ARPI;
You likely can't join if
- PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
- 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...
- Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (a line is counted if at least 2 cycles were administered
- Prior PSMA-directed radiopharmaceutical therapy (radium-223 is allowed);
- Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per...
- Active malignancy other than prostate cancer;
See the full eligibility criteria
- Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
- Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy (serum testosterone level ≤ 1.7 nmol/dL within 60 days from first cycle);
- Biochemically 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 the second of these within 60 days from first...
- PSA ≥2 ng/mL ;
- Prior treatment with at least one ARPI;
- 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;
- ECOG Performance status 0 to 2;
- Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m\^2;
- Albumin ≥ 25 g/L;
- Platelets ≥ 100x10\^9/L;
- Neutrophils ≥ 1.5x10\^9/L;
- Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks;
- Signed, written informed consent
- PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
- 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;
- Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (a line is counted if at least 2 cycles were administered
- Prior PSMA-directed radiopharmaceutical therapy (radium-223 is allowed);
- 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;
- Active malignancy other than prostate cancer;
- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
- Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
- Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
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, but 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 male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.