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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
Be >=18 years of age on day of signing informed consent
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

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 below
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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.
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My cancer has spread to less than 4 places in my bones or lymph nodes.
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My cancer has spread to my bones, confirmed by a bone scan.
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My cancer has spread to lymph nodes outside the pelvis, confirmed by imaging.
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My doctor has identified a lesion that may indicate my cancer has spread.
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My scans from the last 60 days can be used for this study, and I had them before starting hormone therapy.
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I have started hormone therapy for prostate cancer less than 2 months ago.
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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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I have not had surgery or radiation for prostate cancer.
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My testosterone was over 150 ng/dL before starting hormone therapy.
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I agree to have prostate biopsies before and after starting pembrolizumab treatment.
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I agree to use contraception during and up to 120 days after the study.
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My recent tests show my organs are functioning well.
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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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My liver enzymes are within the required limits.
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My blood clotting time is within the normal range, even if I'm on blood thinners.

Timeline

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Abiraterone Acetate
2015
Completed Phase 4
~1880
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~770
Pembrolizumab
2017
Completed Phase 3
~2050
SD-101
2014
Completed Phase 2
~90
Prednisone
2014
Completed Phase 4
~2370
Leuprolide acetate
2007
Completed Phase 4
~630

Find a Location

Who is running the clinical trial?

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
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,757 Total Patients Enrolled
28 Trials studying Prostate Cancer
1,930 Patients Enrolled for Prostate Cancer

Media Library

Leuprolide acetate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03007732 — Phase 2
Prostate Cancer Research Study Groups: Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab), Cohort 1: Prostate Only Sites (ADT, SBRT, Pembrolizumab, SD-101), Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab, SD-101), Cohort 2: Prostate and Oligometastatic sites (ADT, SBRT, Pembrolizumab)
Prostate Cancer Clinical Trial 2023: Leuprolide acetate Highlights & Side Effects. Trial Name: NCT03007732 — Phase 2
Leuprolide acetate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03007732 — Phase 2

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
~2 spots leftby Oct 2024