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Pembrolizumab + Therapy for Metastatic Prostate Cancer
Study Summary
This trial is testing a new combination of treatments for prostate cancer that has spread to a few other parts of the body.
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?
Media Library
- My cancer has spread to my bones, confirmed by a bone scan.My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.Your kidney function should be measured according to the hospital's rules.I have had surgery to remove my prostate.My kidney function, measured by creatinine or GFR, is within the normal range.Your blood clotting time is too long.My scans from the last 60 days can be used for this study, and I had them before starting hormone therapy.I have not had surgery or radiation for prostate cancer.I have not had chemotherapy for my prostate cancer.I cannot or choose not to undergo chemotherapy.I have been on antiandrogens for more than 2 months.I have had radiation therapy to my prostate before.I have stable brain metastases and am not on steroids for them.You are able to read and understand the information about the trial and agree to participate by signing a form.I am not on strong immune system suppressing drugs, except for low-dose steroids for adrenal issues.You are allergic to pembrolizumab or any of the ingredients in the medication.My recent tests show my organs are functioning well.Your PSA level is higher than 2 ng/mL before starting hormonal therapy.My testosterone was over 150 ng/dL before starting hormone therapy.You need to have at least 100,000 platelets per microliter of blood.My liver enzymes are within the required limits.I agree to have prostate biopsies before and after starting pembrolizumab treatment.Your albumin level in your blood is higher than 2.5 mg/dL.Your bilirubin levels in the blood are not too high.You have enough infection-fighting white blood cells.I have been on hormone therapy for more than 2 months.My cancer has spread to less than 4 places in my bones or lymph nodes.I am using or considering herbal therapies for my condition.I am not a candidate for targeted radiation for prostate or limited metastases.I have started hormone therapy for prostate cancer less than 2 months ago.My blood clotting time is within the normal range, even if I'm on blood thinners.I agree to use contraception during and up to 120 days after the study.My doctor has identified a lesion that may indicate my cancer has spread.I am 18 years old or older.My cancer has spread to lymph nodes outside the pelvis, confirmed by imaging.My cancer does not have neuroendocrine or small cell features.My cancer has not spread to my liver.I am fully active or restricted in physically strenuous activity but can do light work.My prostate cancer was confirmed through a tissue examination.I have not taken estrogen for more than 2 months before agreeing to this study.I have mild to moderate nerve damage but can still qualify for the study.I have an active TB infection.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.I have fully recovered from any major surgery before starting this trial.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or cervical cancer that's been treated.I have received immunotherapy or chemotherapy for prostate cancer.
- Group 1: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
- Group 2: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)
- Group 3: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)
- Group 4: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)
- 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 enrollment capacity of this clinical trial?
"At this moment, no patients are being recruited for the trial initially posted on May 17th 2017 and last edited on September 20th 2022. If one is looking to join alternative studies, 1252 clinical trials involving prostate cancer have open positions while 1366 research projects using Pembrolizumab need volunteers."
Has Pembrolizumab been granted regulatory clearance by the FDA?
"Our team at Power gave Pembrolizumab a score of 2 on the safety scale because this is Phase 2, so there exist data points that confirm its security profile yet no evidence to suggest efficacy."
Is the participant enrollment for this clinical trial still open?
"Clinicaltrials.gov states that this trial, which was initially listed on May 17th 2017 and last updated on September 20th 2022, is not currently seeking participants. Nonetheless, there are 2618 other trials actively recruiting patients at present."
Could you provide an overview of the research conducted on Pembrolizumab?
"Currently, Pembrolizumab is the focus of 1366 live trials with 239 in Phase 3. Primarily based in Minneapolis, Minnesota, there are 57144 distinct locations running clinical trials for this medication."
In what ways can Pembrolizumab help patients with various ailments?
"Primarily used to treat inoperable melanoma, pembrolizumab also presents a potential therapeutic intervention for microsatellite instability high, ulcerative colitis and other diseases with an elevated risk of recurrence."
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