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Radioisotope Therapy

177Lu-PSMA-617 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Scott Tagawa, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have normal organ and marrow function as defined below: Absolute neutrophil count >2,000 cells/mm3, Hemoglobin ≥9 g/dL, Platelet count >150,000 x 109/uL, Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal, Serum AST and ALT <1.5 x ULN, Ability to understand and the willingness to sign a written informed consent document
Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new drug to treat prostate cancer. The goal is to see what is the highest dose that can be given without severe side effects.

Who is the study for?
This trial is for adults over 18 with advanced prostate cancer that's spreading and getting worse despite low testosterone levels and previous treatments like enzalutamide or taxane chemotherapy. Participants must have good organ function, no brain metastases, not be on certain bone medications recently, and agree to use birth control if they can have children.Check my eligibility
What is being tested?
The study is testing different doses of a drug called 177Lu-PSMA-617 to find the highest dose that doesn't cause severe side effects in men with progressive metastatic CRPC (a type of prostate cancer). The drug targets cancer cells using a radioactive substance linked to a molecule that binds to PSMA receptors on tumors.See study design
What are the potential side effects?
Possible side effects from the treatment may include nausea, fatigue, dry mouth, changes in blood counts leading to increased risk of infections or bleeding. There might also be kidney damage due to the radioactivity as well as potential radiation exposure-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is worsening, shown by rising PSA levels, new bone lesions, or growth in scans.
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I can take care of myself and perform daily activities.
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My prostate cancer was confirmed by a lab test.
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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617
Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617
Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen
Secondary outcome measures
Count of Participants That Experience an Adverse Event
Count of Patients That Had a Radiographic Response Rate Measured by RECIST 1.1 With PCWG3 Modifications
Number of CTC Count Responders
+3 more
Other outcome measures
Disease assessment with 68Ga-PSMA-HBED-CC PET/CT prior to and following investigational treatment
Genomic DNA repair pathways in relationship to outcome following fractionated dose 177Lu-PSMA-617 by collecting archival pathology tissue.
Patient reported outcomes using Functional Assessment Cancer Therapy-Prostate
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All subjectsExperimental Treatment2 Interventions
177Lu-PSMA-617 [50mCi (1.85GBq) - 300mCi (11.1GBq)] intravenous X2 doses, 2 weeks apart (Visit 1 and 2) 68Ga-PSMA-HBED-CC [5 ±2mCi or 185 ±74MBq] intravenous during screening and at 12 weeks with standard imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga-PSMA-HBED-CC
2017
Completed Phase 2
~20
177Lu-PSMA-617
2018
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,478 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,589 Patients Enrolled for Prostate Cancer
Scott Tagawa, MDPrincipal InvestigatorWeill Medical College of Cornell University
7 Previous Clinical Trials
199 Total Patients Enrolled
6 Trials studying Prostate Cancer
179 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting elderly individuals?

"According to the criteria, individuals between 18 and 99 are eligible for this research project. Subsequently, there is a separate study involving people under 18 as well as one that involves persons above 65 years of age; with 75 trials in the former group and 1321 in the latter."

Answered by AI

Are there any precedent experiments involving 177Lu-PSMA-617?

"Currently, 12 clinical trials are in progress and evaluating the efficacy of 177Lu-PSMA-617. One trial is already at Phase 3 status. Most studies occur in Brooklyn, NY but there are 16 additional sites conducting investigations into this drug's potential benefits."

Answered by AI

What medical treatments is 177Lu-PSMA-617 typically used to address?

"Commonly, tumor antigens are treated with 177Lu-PSMA-617. This medication is also beneficial in the treatment of suspected metastasis and prostate cancer as well as positron emission tomography imaging."

Answered by AI

What is the aggregate participant count for this experiment?

"This particular trial is no longer taking partcipants. It first appeared on December 1st, 2016 and was last modified on November 20th 2021. However, if you are searching for other trials related to prostate cancer there are 1315 clinical studies currently enrolling patients while 12 of those specifically focus on 177Lu-PSMA-617 therapies."

Answered by AI

Are there any vacancies remaining in this clinical trial?

"Per the information on clinicaltrials.gov, this medical trial is currently not taking applications from potential participants. Initially posted in December 2016 and last edited November 2021, it does not appear to be actively recruiting at present; however, 1327 other trials are accepting candidates presently."

Answered by AI

Is it possible for me to enroll in this trial?

"This medical experiment is searching for 46 individuals, aged 18 to 99 years old, suffering from prostate cancer. To be eligible for the trial patients must also meet a series of additional conditions including: confirmed adenocarcinoma diagnosis and PSA progression; new bone lesions with objective radiographic soft tissue progressions; ECOG performance status between 0-2; serum testosterone below 50 ng/dL while continuing primary androgen deprivation therapy (LHRH or GnRH); taking an Androgen receptor signalling inhibitor such as enzalutamide or CYP 17 inhibitor like abiraterone acetate; having either received taxane chemotherapy before,"

Answered by AI
Recent research and studies
The ProstateJournal
Imaging Expression of Prostate‐specific Membrane Antigen and Response to Psma‐targeted Β‐emitting Radionuclide Therapies in Metastatic Castration‐resistant Prostate Cancer
Vlachostergios, Panagiotis J., Muhammad Junaid Niaz, Myrto Skafida, Seyed Ali Mosallaie, Charlene Thomas, Paul J. Christos, Joseph R. Osborne, et al.. 2021. “Imaging Expression of Prostate‐specific Membrane Antigen and Response to Psma‐targeted Β‐emitting Radionuclide Therapies in Metastatic Castration‐resistant Prostate Cancer”. The Prostate. Wiley. doi:10.1002/pros.24104.
clinicaltrials.govStudy
Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC
2016. "Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03042468.
~6 spots leftby Apr 2025
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