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Hormone Therapy
Pembrolizumab + Therapy for Metastatic Prostate Cancer
Phase 2
Waitlist Available
Led By Lawrence Fong, MD
Research Sponsored by Lawrence Fong
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hemoglobin >=9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) <=1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN. Creatinine clearance should be calculated per institutional standard
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
Men over 18 with newly diagnosed hormone-naive oligometastatic prostate cancer, who haven't had chemotherapy or surgery for it, and have fewer than four metastases. They must be able to consent, have good organ function and performance status (able to carry out daily activities), agree to use contraception, and not be on certain other treatments.Check my eligibility
What is being tested?
The trial is testing the combination of radiation therapy and pembrolizumab immunotherapy with or without SD-101 injected into tumors in patients with limited-spread prostate cancer. It's an open-label Phase 2 study where everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, skin reactions at injection sites, changes in blood tests reflecting liver or kidney issues. Pembrolizumab can also cause infusion-related symptoms like fever or chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hemoglobin level is at least 9 g/dL without needing transfusions or EPO recently.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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I have not had surgery or radiation for prostate cancer.
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I have not had chemotherapy for my prostate cancer.
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I cannot or choose not to undergo chemotherapy.
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My testosterone was over 150 ng/dL before starting hormone therapy.
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My liver enzymes are within the required limits.
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My cancer has spread to less than 4 places in my bones or lymph nodes.
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I have started hormone therapy for prostate cancer less than 2 months ago.
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I agree to use contraception during and up to 120 days after the study.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer was confirmed through a tissue examination.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change Rate of prostate-specific antigen (PSA) < nadir + 2 ng/mL from first day of treatment to 15 months (Cohort 2)
Number of participants with treatment-related adverse events
Secondary outcome measures
Progression-free survival (PFS) (Cohort 2)
Rate of testosterone-PSA uncoupling (Cohort 2)
Time to clinical progression (Cohort 2)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101)Experimental Treatment6 Interventions
Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1.
TLR9 agonist SD-101: Injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1
Pembrolizumab: Given IV every 21 days for up to 13 doses
Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland and oligometastatic sites via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Group II: Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)Experimental Treatment5 Interventions
Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1.
Pembrolizumab: Given IV every 21 days for up to 13 doses
Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland and oligometastatic sites via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Group III: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101)Experimental Treatment6 Interventions
Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1.
TLR9 agonist SD-101: Injected into the dominant prostatic tumor lesion at time of fiducial marker placement (1-5weeks prior to Cycle 1 Day 1) and 1-3 weeks after Cycle 1 Day 1
Pembrolizumab: Given IV every 21 days for up to 13 doses
Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Group IV: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab)Experimental Treatment5 Interventions
Three month androgen deprivation therapy (ADT) run-in followed by leuprolide injected intramuscularly every 3 months for 3 doses (or another FDA approved gonadotropin-releasing hormone agent for 9 months) + abiraterone by mouth daily with prednisone by mouth daily (or equivalent medication per local standard practice) for 9 months starting on Day 1.
Pembrolizumab: Given IV every 21 days for up to 13 doses
Radiotherapy: Given every other day over 10-14 days delivered to the whole prostate gland via stereotactic body radiation therapy (SBRT) starting 1-2 weeks after marker placement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780
Abiraterone Acetate
2015
Completed Phase 4
~1880
Pembrolizumab
2017
Completed Phase 2
~2010
SD-101
2014
Completed Phase 2
~90
Leuprolide acetate
2007
Completed Phase 4
~630
Find a Location
Who is running the clinical trial?
Dynavax Technologies CorporationIndustry Sponsor
28 Previous Clinical Trials
17,357 Total Patients Enrolled
TriSalus Life Sciences, Inc.Industry Sponsor
4 Previous Clinical Trials
249 Total Patients Enrolled
Lawrence FongLead Sponsor
5 Previous Clinical Trials
110 Total Patients Enrolled
2 Trials studying Prostate Cancer
68 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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)
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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