Malignant Neoplasm of Prostate study: Lu-PSMA-617
Official title STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT06574880
What this study is testing
What is Lu-PSMA-617?
Lu-PSMA-617 is an investigational medicine, being studied as a potential treatment for malignant neoplasm of prostate.
Also referred to as 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
- The study wants to see if using Pluvicto instead of standard hormone therapy can reduce cancer return and keep quality of life high.
- Who it's for
- Men with locally advanced prostate cancer who are eligible for radiation treatment.
- What's involved
- Participants get one dose of Pluvicto, then radiation in five sessions over two weeks, followed by a second Pluvicto dose six weeks later. Some may receive a third dose six weeks after the second.
- Time commitment
- The treatment course lasts about 12 weeks, with visits for drug injections and radiation sessions as scheduled.
- Phase 2: a mid-size study of how well it works
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
- Participant must be ≥ 18 years of age.
- ECOG performance status ≤ 1
- Histologic confirmation of prostate adenocarcinoma of the prostate
- PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.
- PSMA PET/CT must be obtained within 4 months.
You likely can't join if
- Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging.
- Prostate gland size \>90 cc measured by CT, ultrasound, or MRI
- Prior head and neck radiation therapy.
- Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
- Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
- Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and...
See the full eligibility criteria
- Participant must be ≥ 18 years of age.
- ECOG performance status ≤ 1
- Histologic confirmation of prostate adenocarcinoma of the prostate
- PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10.
- PSMA PET/CT must be obtained within 4 months.
- Pelvic nodal disease (cN1) as defined by LN stations that commence at the bifurcation of the common iliac vessels
- Regional nodal disease (M1a) as defined by LN stations that commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
- In the absence of nodal metastasis, must have ≥ 2 of the following
- i. cT3a or cT3b by conventional imaging (MRI) or PSMA PET/CT
- ii. Grade group ≥ 4
- iii. PSA ≥ 40 ng/mL
- Hemoglobin \> 10 g/dL
- White blood cell (WBC) \> 3000 / mL
- Absolute neutrophil count ≥ 1,500 / mcL
- Platelets ≥ 100,000 / mcL
- Creatinine ≤ 1.5x ULN
- Estimated glomerular filtration rate (eGFR)\ \> 50 mL/min
- Total bilirubin\ \ \< 2× ULN
- Albumin \> 3 g/dL
- Aspartate aminotransferase (AST) \< 3× ULN
- \ based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only participants with non-obstructive...
- \ \ Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted)
- International Prostate Symptoms Score (IPSS) ≤ 15.
- Medically fit for treatment and agreeable to follow-up.
- Ability to understand and the willingness to sign a written informed consent.
- Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617.
- Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation.
- Prostate gland size \>90 cc measured by CT, ultrasound, or MRI
- Prior head and neck radiation therapy.
- Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy).
- Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
- Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals.
- History of prior pelvic radiation therapy.
- Enrollment concurrently in another investigational drug study within 6 months of registration.
- History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer.
- History of prior myelodysplastic syndrome or acute leukemia.
- History of or active Crohn's disease or ulcerative colitis.
- Contraindication to or inability to tolerate PSMA/PET.
- Any condition that in the opinion of the investigator would preclude participation in this study.
- Inability to adhere to radiation safety measures in hospital or at home
- Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other
- Reduced salivary gland function with baseline CTCAE Gr \> 1 dry mouth will be excluded.
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
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 Cleveland, Ohio, United States. 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.