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New treatment option for Prostate Cancer
Official title Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
ClinicalTrials.gov ID: NCT07054346
What this study is testing
What is 177 Lutetium Prostate-Specific Membrane Antigen 617?
177 Lutetium Prostate-Specific Membrane Antigen 617 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Also referred to as 177Lu-PSMA-617, 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
- There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.
- Phase 1: an early, usually small safety study
- Time commitment: about 60 months
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
- Histologically confirmed prostate adenocarcinoma.
- Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.
- High-risk disease as defined as meeting 1 or more of the 3 following criteria:
- Gleason score of 4+5 disease or higher.
- Pelvic nodal metastases on PSMA PET.
You likely can't join if
- Has received prior prostate cancer therapy. a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3...
- Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four...
- Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).
- Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III...
- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a...
- Individuals with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it...
See the full eligibility criteria
- Histologically confirmed prostate adenocarcinoma.
- Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.
- High-risk disease as defined as meeting 1 or more of the 3 following criteria:
- Gleason score of 4+5 disease or higher.
- Pelvic nodal metastases on PSMA PET.
- Extracapsular extension or seminal vesicle invasion on MRI.
- No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease below the iliac bifurcation (clinical stage N1) is allowed.
- Maximum Standardized Uptake Value (SUVmax) in the primary tumor greater than 10 on PSMA PET using Gallium-68 (68Ga)-PSMA-11 or piflufolastat F 18 (18F-DCFPyL).
- Target tumor in the prostate measuring greater than 1.5 cm on MRI.
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%),
- Demonstrates adequate organ function as defined below:
- Platelets ≥100,000/mcL, independent of transfusions or growth factors within 3 months of treatment start.
- Hemoglobin ≥10 g/dL, independent of transfusions or growth factors within 3 months of treatment start.
- Absolute Neutrophil Count (ANC) ≥1,500/microliter (mcL).
- Creatinine clearance Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 , calculated using the Cockcroft-Gault equation.
- Albumin ≥2.5 g/dL.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN.
- Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must provide consent to comply to recommended radioprotection precautions during study.
- Participants must use adequate contraception and not donate sperm while on study drug and for at least 14 weeks after the last study treatment.
- Has received prior prostate cancer therapy. a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.
- Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four weeks of the first dose of treatment.
- Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).
- Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT...
- Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who...
- Individuals with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Prior external beam radiation therapy (EBRT) to the prostate or prostate bed. Additional exclusion criteria applicable only to participants undergoing intraarterial administration of PSMA RLT:
- Severe allergy to iodinated contrast.
- Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 60 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.