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Radioisotope Therapy
177Lu-PSMA-617 + SBRT for Prostate Cancer
Phase 1
Waitlist Available
Led By Brandon Imber, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patient must have normal organ and marrow function as defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective. The treatment combines two existing treatments: a drug that targets cancer cells and radiation therapy. The researchers think this new combination may be better at preventing or delaying cancer growth than either treatment alone.
Who is the study for?
This trial is for men with prostate cancer who've had primary treatment at least 2 years ago, have a specific type of tumor detectable by PSMA scan, and haven't received recent prostate-cancer therapy. They must be healthy enough for radiation therapy, not have castration-resistant cancer or certain other health conditions, and agree to use contraception.Check my eligibility
What is being tested?
The study tests if combining a targeted radioactive drug called 177Lu-PSMA-617 with Stereotactic Body Radiotherapy (SBRT) is safe and effective in treating prostate cancer that has spread but is limited in number and location.See study design
What are the potential side effects?
Possible side effects include reactions related to radiation exposure such as skin changes or fatigue, kidney function changes due to the radioactive drug, blood count alterations leading to increased infection risk or bleeding problems, and gastrointestinal issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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My organs and bone marrow are functioning normally.
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I am 18 years old or older.
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My initial cancer was treated with surgery or radiation.
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My cancer that has spread to a few places can be treated with targeted radiation.
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My kidney function is within the normal range.
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I haven't had prostate cancer treatment since my last PSMA scan.
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I have 1-3 small cancer spread areas in bone or soft tissue seen on a PSMA PET scan.
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My prostate cancer diagnosis was confirmed with a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic Body Radiotherapy and 177Lu-PSMA-617Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
177Lu-PSMA-617
2018
Completed Phase 3
~840
Stereotactic Body Radiotherapy (SBRT)
2016
Completed Phase 3
~580
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,616 Total Patients Enrolled
132 Trials studying Prostate Cancer
52,068 Patients Enrolled for Prostate Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,344 Total Patients Enrolled
32 Trials studying Prostate Cancer
5,832 Patients Enrolled for Prostate Cancer
Brandon Imber, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.My liver function tests are within normal ranges.My insurance covers SBRT treatment or I can pay for it myself.I currently have an active infection.I have not had any cancer except for skin cancer in the last 3 years.My organs and bone marrow are functioning normally.I am not allergic to Lu-PSMA-617 or its components.My cancer has spread, and it can't be treated with a specific type of radiation without risking damage to nearby organs.I have or had hepatitis or chronic liver disease with symptoms.I am 18 years old or older.My prostate cancer is not the common type but a rare form like small cell or neuroendocrine.I have spinal cord compression or brain metastases.I have a digestive condition that affects how my body absorbs food.My PSMA scan shows either no spread or more than 3 cancer spots.I have seizures or a condition that could cause them.I have had issues with my pituitary or adrenal glands.I have or might have moderate to severe kidney disease.My initial cancer was treated with surgery or radiation.I agree to use contraception during the study due to unknown effects on fetuses.I haven't had severe heart issues or blood clots in the last 6 months.My cancer that has spread to a few places can be treated with targeted radiation.I have not had extensive radiation therapy or treatments with specific radioactive compounds.I am not taking steroids, PC-SPES, finasteride, or dutasteride.My kidney function is within the normal range.My cancer has spread, and it does not show PSMA or shows mixed PSMA results.I haven't had prostate cancer treatment since my last PSMA scan.I have 1-3 small cancer spread areas in bone or soft tissue seen on a PSMA PET scan.I have had treatment for my prostate cancer before.I had radiation for a few cancer spread sites and am still eligible.My prostate cancer diagnosis was confirmed with a biopsy.My testosterone levels are normal after stopping hormone therapy for the last year.My recent prostate MRI or biopsy was negative.My prostate cancer is resistant to hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic Body Radiotherapy and 177Lu-PSMA-617
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor still recruiting participants?
"The data found on clinicaltrials.gov suggests that enrollment for this medical study has closed, with the original post date being October 1st 2021 and last update on November 17th 2022. Despite this specific trial no longer looking for participants, there are still 1321 other studies actively recruiting patients at present."
Answered by AI
What risks does 177Lu-PSMA-617 pose to humans?
"Our team at Power has assigned 177Lu-PSMA-617 a score of 1 due to the limited amount of clinical data available in regards to its safety and efficacy, as this is only a Phase 1 trial."
Answered by AI
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