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177Lu-PSMA-617 + Pembrolizumab for Prostate Cancer
Study Summary
This trial is testing a combination of two drugs to treat prostate cancer that has spread. The first drug, 177Lu-PSMA-617, is a radioactive agent that targets and kills cancer cells. The second drug, pembrolizumab, is an immunotherapy that helps the body's immune system attack the cancer. The combination of these two drugs may be more effective at treating prostate cancer than either drug alone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I had radiotherapy over 2 weeks ago, with no ongoing side effects and didn't need steroids.If you have had a procedure called vasectomy, which prevents pregnancy, you will still be considered capable of having children for this study.I have a history of hepatitis B or active hepatitis C.I have previously received treatment targeting PSMA.I have a bleeding disorder but am not on blood thinners that can't be stopped for a biopsy.I have brain metastases that have not been treated.I have had radiation on more than 25% of my bone marrow or within the last 14 days.I am unable to give informed consent due to my age or health condition.I have previously received treatments like pembrolizumab or other immune checkpoint inhibitors.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had a heart attack, unstable chest pain, or stroke in the last 6 months.I am willing to have a tumor biopsy and have at least one tumor that can be safely biopsied.My testosterone levels are very low, and I am on or will continue hormone therapy if I haven't had surgery to remove my testicles.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't needed steroids for 2 weeks before starting the study treatment.I will use birth control during and for 60 days after the study.My last treatment was more than 28 days ago.My cancer progressed after treatment with a specific hormone therapy.I have not received a live vaccine within the last 30 days.I do not have serious heart problems.I have had serious lung inflammation in the past 2 years or have it now.I have recovered from any major surgery before starting the study treatment.You have recently been in another research study or used an experimental treatment within the last 4 weeks.I do not have severe numbness, pain, or weakness in my hands or feet.My prostate cancer is worsening despite hormone therapy.You have a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.I am currently being treated for an infection.I have been diagnosed with prostate cancer, not the small cell neuroendocrine type.My PET scan shows at least three lesions more active than my liver.My partner can potentially become pregnant.I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, whichever is shorter. Any side effects from past treatments are mild.I have an active TB infection.I have received taxane chemotherapy for hormone-resistant cancer.I have not had major surgery in the last 4 weeks.I have severe heart failure that is not well-managed.I am fully active or have some restrictions but can still care for myself.My kidney function, measured by creatinine or GFR, is within the normal range.I have received radium-223 or similar treatments for prostate cancer.My heart rhythm problem is not controlled by medication, but I don't have chronic or occasional atrial fibrillation/flutter.
- Group 1: Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab)
- Group 2: Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab)
- Group 3: Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the intended outcome of this experiment?
"The primary goal of this clinical trial is to determine the recommended phase 2 dose, and it will be measured from the beginning of treatment up until disease progression or recurrence. Secondary objectives include estimating median PSA progression-free survival rate using Kaplan Meier Method; determining radiographic progression-free survival (rPFS) rate by RECIST version 1.1 Prostate cancer Working Group (PCWG)3 criteria; and assessing frequency/severity of adverse events according to CTCAE version 4.0 standards."
Are there any accessible positions left in this research trial for individuals?
"At this stage, enrollment for the trial has closed. Initially posted on May 10th 2019 and last updated April 11th 2022, the study is no longer searching for participants. If you are seeking other opportunities to take part in research studies involving carcinoma or pembrolizumab treatments, there are currently 3680 and 992 trials respectively that require volunteers."
Are there any prior instances of Pembrolizumab being used in clinical trials?
"Presently, there are 992 Pembrolizumab trials ongoing with 125 in the third stage of development. Houston is at the centre of most research endeavours for this medication but it can be accessed from 36009 other locations as well."
Has the Federal Drug Administration acknowledged Pembrolizumab?
"The safety of pembrolizumab has been evaluated at a level 1, since this is an early-stage trial and limited evidence exists to support its efficacy or safety."
What is the scope of enrollment for this research endeavor?
"Unfortunately, enrollment for this medical trial has temporarily closed. It was initially posted on May 10th 2019 and underwent its last revision on April 11th 2022. If you're still seeking clinical trials, there are currently 3680 studies involving carcinoma that are accepting participants and 992 research projects utilizing Pembrolizumab actively enrolling patients."
In what circumstances is Pembrolizumab usually recommended?
"Pembrolizumab is commonly employed to battle malignant neoplasms, as well as other medical ailments such as microsatellite instability high, unresectable melanoma and post-chemotherapy disease progression."
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