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PD-1 Inhibitor
Pembrolizumab for Prostate Cancer (PICT-01 Trial)
Phase 2
Recruiting
Led By Yves Fradet, MD
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-metastatic prostate cancer with histologically confirmed Gleason sum ≥8
Provided archival formalin-fixed, paraffin embedded tumor biopsy of the prostate tumor lesion not previously irradiated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of study completion, an average of 3 years
Awards & highlights
PICT-01 Trial Summary
This trial is testing if a drug called Pembrolizumab can help treat prostate cancer. The study is looking for biomarkers, which are biological signs, that can predict if the drug will work. The study is for men with prostate cancer who are at high risk of the cancer progressing.
Who is the study for?
Men over 18 with non-metastatic prostate cancer, Gleason score ≥8, and high glucose metabolism in the prostate as shown by PET scans. They must have good organ function, no prior hormone therapy for cancer, and be fit enough for surgery. Excluded are those with active autoimmune diseases treated within 2 years, infections needing systemic treatment, HIV or hepatitis B/C history, recent live vaccines or immunosuppressive drugs.Check my eligibility
What is being tested?
The trial is testing Pembrolizumab's effectiveness when given before surgical removal of the prostate in patients at high risk of cancer progression. It aims to identify biomarkers that predict how well these patients respond to this anti-PD1 immunotherapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), skin reactions, liver problems (hepatitis), hormonal gland issues like thyroid disorders and can also lead to severe allergic reactions.
PICT-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is aggressive but has not spread, with a Gleason score of 8 or more.
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I have provided a biopsy sample of my prostate tumor that was not treated with radiation.
Select...
I am not undergoing hormone therapy for cancer.
Select...
I am a man aged 18 or older.
Select...
I have not had hormone therapy before surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.
PICT-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the end of study completion, an average of 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of study completion, an average of 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immune cell infiltration and immune checkpoint expression
Mean difference change in proliferative index in prostate cancer patients between patients treated with pembrolizumab and the control cohort
The antitumor activity of pembrolizumab assessed as the tumor response rate based on the change in tumor volume as measured by 18FDG-PET
Secondary outcome measures
Assess a possible correlation between deficient mismatched repair (dMMR) and microsatellite instability-high (MSI-H) and response to pembrolizumab.
Eicosanoids
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
PICT-01 Trial Design
1Treatment groups
Experimental Treatment
Group I: Prostate CancerExperimental Treatment1 Intervention
Participants will receive 3 cycles of pembrolizumab regardless of PD-L1 status. After completion of the second cycle of pembrolizumab treatment, and just before the third injection of pembrolizumab an 18FDG-PET/CT scan will be performed to assess a potential metabolic response. Then between 2 to 4 weeks after the third treatment, subjects will undergo radical prostatectomy. Subjects will be followed every 3 months during the first year post-surgery and according to physician decision during the following years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
107,127 Total Patients Enrolled
12 Trials studying Prostate Cancer
3,812 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,116 Total Patients Enrolled
26 Trials studying Prostate Cancer
16,967 Patients Enrolled for Prostate Cancer
Yves Fradet, MDPrincipal InvestigatorCHU de Québec-Université Laval
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Prostate Cancer
6 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.You have a history of mental health or substance abuse issues that could make it difficult to participate in the trial.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I have a history of Hepatitis B or an active Hepatitis C infection.My prostate cancer is aggressive but has not spread, with a Gleason score of 8 or more.I am scheduled for major prostate surgery within 6 to 9 weeks.I have had or currently have lung inflammation treated with steroids.I have not had another type of cancer in the last 3 years.I have provided a biopsy sample of my prostate tumor that was not treated with radiation.I am not undergoing hormone therapy for cancer.You have been in another research study or used an experimental device within the last 4 weeks.I am currently being treated for an infection.I have been diagnosed with HIV.I am a man aged 18 or older.I have not received a live vaccine in the last 30 days.I have not had any cancer treatment or experimental drugs in the last 4 weeks.I have been treated with specific immune therapy for cancer.I had radiation therapy on my prostate or other organs less than 2 weeks ago.I have not had hormone therapy before surgery.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Prostate Cancer
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.
Are there any precedents for the utilization of Pembrolizumab in medical research?
"Initially, 961 different studies were being conducted to evaluate the efficacy of Pembrolizumab. Currently, 122 of those investigations are at Phase 3 and 35727 medical sites in total hold trials for this medication. Houston, Texas holds the most with a significant amount of research occurring there."
Answered by AI
What is the total number of participants that have been included within this research endeavor?
"Affirmative. Information hosted on clinicaltrials.gov reveals that this medical trial is seeking participants, with postings initially made in January of 2020 and the most recent updates occurring in March 2022. A total of 30 individuals are being recruited from a single site."
Answered by AI
Has Pembrolizumab received federal regulatory approval?
"The safety of Pembrolizumab was evaluated as a 2, taking into consideration the fact that this is only in Phase 2. Data collected thus far supports its security but more studies are needed to verify efficacy."
Answered by AI
What are the common applications of Pembrolizumab?
"Pembrolizumab is a viable treatment option for malignant neoplasms, unresectable melanoma, and cases of microsatellite instability high."
Answered by AI
Are there still openings for participants in this trial?
"Affirmative. Clinicaltrials.gov provides evidence that the clinical trial is actively enrolling participants, which began on 10th of January 2020 and was recently modified on 8th of March 2022. This study requires 30 individuals to be enrolled from a single location."
Answered by AI
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