Clinical trial for Metastatic Prostate Cancer
Official title 177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07145177
What this study is testing
What is 177Lu-PSMA-617?
An investigational intravenous drug being studied for metastatic prostate cancer. is designed to target prostate-specific membrane antigen (PSMA) on cancer cells and deliver radioactive radiation to kill them.
Also referred to as Lutetium-177 (177Lu)-PSMA-617.
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 aims to find out whether giving 177Lu‑PSMA‑617 after liver‑directed therapy is safe for patients with advanced prostate cancer that has spread to the liver.
- Who it's for
- Men with metastatic castration‑resistant prostate cancer that has spread to the liver and who have already tried at least one androgen‑pathway drug.
- What's involved
- Participants will receive the 177Lu‑PSMA‑617 treatment and a liver‑directed therapy, and will be monitored for side effects and safety.
- Time commitment
- Participants will attend scheduled visits for treatment and safety monitoring as directed by the study.
- 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
- Histologically confirmed prostate cancer.
- Progressive disease by PCWG3 criteria at study entry.
- Male participants who are at least 18 years of age on the day of signing informed consent.
- Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on...
- Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or...
You likely can't join if
- De novo small cell neuroendocrine prostate cancer.
- Grossly extrahepatic soft tissue disease on screening CT that is negative on PSMA PET. Non-PSMA avid liver lesions are allowed.
- Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study...
- Recipient of more than one cycle of PSMA-directed radioligand treatment. Up to one treatment cycle is allowed prior to study enrollment.
- Recipient of \> 2 lines of prior taxane-based chemotherapy administered in the castration-resistant setting.
- Previous bilio-enteric anastomosis, ampulla of Vater sphincterotomy, biliary stent, or biliary drain passing through the ampulla of Vater.
See the full eligibility criteria
Who can join
- Histologically confirmed prostate cancer.
- Progressive disease by PCWG3 criteria at study entry.
- Male participants who are at least 18 years of age on the day of signing informed consent.
- Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for...
- Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide.
- Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade ≤ 1 (except for any grade alopecia and grade ≤ 2 neuropathy).
- Prior external beam radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on Cycle 1 Day 1 (C1D1).
- At least one PSMA-avid extrahepatic lesion on screening PSMA Positron Emission Tomography (PET). A positive lesion is defined as uptake above background liver. Hepatic lesions may be PSMA PETnegative or positive.
- Availability of archival mCRPC tissue, or presence of a metastatic lesion that is amenable to fresh biopsy and willingness to undergo biopsy during screening if no archival mCRPC tissue available.
- The presence of one or more liver metastases amenable to liver-directed therapy in the judgment of the treating treatment radiologist.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky ≥ 50%.
- Absolute neutrophil count ≥ 1,500/ microliter (mcL).
- Platelets ≥ 100,000/mcL.
- Hemoglobin \> 9.0 g/dL.
- Total bilirubin ≤ 2 x upper limit of normal (ULN). In participants with known or suspected Gilbert's disease, direct bilirubin ≤ ULN.
- aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 5 x institutional upper limit of normal.
- alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 5 x institutional upper limit of normal.
- Prothrombin time ≤ 1.5 x institutional upper limit of normal (unless on medical therapy known to prolong prothrombin time).
- Albumin ≥ 2.8 g/dL
- Creatinine clearance Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2, calculated using the Cockcroft-Gault equation or 24 hour urine collection.
- Last treatment was \> 28 days prior to C1D1
- No evidence of new/progressive brain metastases is observed on MRI obtained during the Screening window
- Participants must use appropriate methods of contraception during study treatment and for at least 6 months after last study treatment.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- De novo small cell neuroendocrine prostate cancer.
- Grossly extrahepatic soft tissue disease on screening CT that is negative on PSMA PET. Non-PSMA avid liver lesions are allowed.
- Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception and are permitted.
- Recipient of more than one cycle of PSMA-directed radioligand treatment. Up to one treatment cycle is allowed prior to study enrollment.
- Recipient of \> 2 lines of prior taxane-based chemotherapy administered in the castration-resistant setting. Prior taxane in the castration sensitive setting does not count towards this limit.
- Previous bilio-enteric anastomosis, ampulla of Vater sphincterotomy, biliary stent, or biliary drain passing through the ampulla of Vater.
- Currently participating in a study of an investigational therapeutic agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D1.
- Uncontrolled or any New York Heart Association Class 3 or 4 congestive heart failure.
- Uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months before study entry.
- Clinically significant arrhythmias not controlled by medication. Note: Chronic rate-controlled or paroxysmal atrial fibrillation/flutter is not an exclusion to study participation.
- Major surgery within 28 days of study treatment. Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study...
- Has a secondary malignancy requiring active treatment at study entry (except for carcinoma-in-situ, non-muscle invasive bladder cancer, and non-melanoma skin cancer).
- Has an active infection requiring intravenous antibiotics within 7 days prior to C1D1.
- Participants who are HbsAg positive are eligible if they have received hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study entry.
- Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to study entry.
- History of bleeding diathesis and currently on anti-coagulation therapy that cannot be safely discontinued for liver directed therapy.
- Clinically significant ascites including requiring more than one paracentesis in the 28 days prior to C1D1.
- Unable or unwilling to follow radiation safety precautions following each dose of radioligand therapy or liver directed therapy.
- Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, 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 San Francisco, California, 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.