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PD-1 Inhibitor

Pembrolizumab for Prostate Cancer (PICT-01 Trial)

Phase 2

Waitlist Available

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

Must not have

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of study completion, an average of 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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I am not undergoing hormone therapy for cancer.

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I am a man aged 18 or older.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.

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I have had or currently have lung inflammation treated with steroids.

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I have not had another type of cancer in the last 3 years.

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I have been treated with specific immune therapy for cancer.

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I had radiation therapy on my prostate or other organs less than 2 weeks ago.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Assess a possible correlation between deficient mismatched repair (dMMR) and microsatellite instability-high (MSI-H) and response to pembrolizumab.

Eicosanoids

One year PSA (Prostate Specific Antigen) failure rate

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

0 / 13Eligibility criteria met