Pembrolizumab for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
CHU de Québec-Université Laval, Québec, Canada
Prostate Cancer+1 More
Pembrolizumab - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a PET scan can predict which patients with prostate cancer will respond to immunotherapy.

See full description

Eligible Conditions

  • Prostate Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 3 primary outcomes and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Through study completion, an average of 1 year.

Year 3
Assess a possible correlation between deficient mismatched repair (dMMR) and microsatellite instability-high (MSI-H) and response to pembrolizumab.
Assess the expression of a series of cytokines and eicosanoids
One year PSA (Prostate Specific Antigen) failure rate
Year 1
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
Year 2
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
Number of participants with decrease in SUV uptake after 3 cycles of pembrolizumab

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Pembrolizumab + Etoposide
Neutropenia
54%
Anaemia
45%
Nausea
38%
Alopecia
34%
Decreased appetite
31%
Constipation
29%
Fatigue
27%
Thrombocytopenia
26%
Leukopenia
22%
Cough
20%
Diarrhoea
20%
Asthenia
17%
Dyspnoea
17%
Vomiting
16%
Pyrexia
14%
Dizziness
14%
Rash
13%
Headache
13%
Insomnia
11%
Pruritus
11%
Back pain
11%
Hypothyroidism
10%
Weight decreased
10%
Hyponatraemia
9%
Aspartate aminotransferase increased
9%
Arthralgia
9%
Oedema peripheral
8%
Alanine aminotransferase increased
8%
Pneumonia
8%
Blood creatinine increased
7%
Upper respiratory tract infection
7%
Febrile neutropenia
7%
Abdominal pain
7%
Hypokalaemia
7%
Abdominal pain upper
6%
Stomatitis
6%
Hyperthyroidism
6%
Dysgeusia
6%
Dry skin
6%
Dysphagia
5%
Dyspepsia
5%
Blood alkaline phosphatase increased
5%
Chest pain
5%
Musculoskeletal pain
5%
Erythema
5%
Hypertension
5%
Nasopharyngitis
5%
Musculoskeletal chest pain
5%
Pain in extremity
5%
Hypotension
4%
Pneumonitis
2%
Pulmonary embolism
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Neutropenic sepsis
1%
Inappropriate antidiuretic hormone secretion
1%
Transient ischaemic attack
1%
Hemiparesis
1%
Superior vena cava syndrome
1%
Diabetes mellitus
1%
Pneumothorax
1%
Gastritis
1%
Aortic aneurysm
1%
Sepsis
1%
Pleural infection
1%
Infusion related reaction
1%
Clostridium difficile colitis
1%
Urinary tract infection
1%
Joint injury
0%
Embolism
0%
Dehydration
0%
Escherichia sepsis
0%
Empyema
0%
Aphasia
0%
Hypoxia
0%
Hypertensive crisis
0%
Cerebrovascular accident
0%
Food poisoning
0%
Deep vein thrombosis
0%
Myocardial infarction
0%
Acute coronary syndrome
0%
Hypopituitarism
0%
Vertigo
0%
Appendicitis
0%
Cholecystitis
0%
Skin laceration
0%
Hepatotoxicity
0%
Confusional state
0%
Secondary adrenocortical insufficiency
0%
Lower respiratory tract infection
0%
Tremor
0%
Type 1 diabetes mellitus
0%
Bronchospasm
0%
Prostatitis
0%
Femur fracture
0%
Myocarditis
0%
Vitreous haemorrhage
0%
Infective exacerbation of chronic obstructive airways disease
0%
Serratia sepsis
0%
Laryngeal haemorrhage
0%
Paraneoplastic syndrome
0%
Epistaxis
0%
Benign prostatic hyperplasia
0%
Pneumonia haemophilus
0%
Autoimmune nephritis
0%
Cognitive disorder
0%
Gastrointestinal viral infection
0%
Gouty arthritis
0%
Spinal osteoarthritis
0%
Pseudomonas infection
0%
Cancer pain
0%
Chronic obstructive pulmonary disease
0%
Subacute cutaneous lupus erythematosus
0%
Peripheral embolism
0%
Spinal fracture
0%
Tooth infection
0%
Haemoptysis
0%
Decubitus ulcer
0%
Diverticulum
0%
Cholecystitis infective
0%
Pericardial effusion
0%
Loss of consciousness
0%
Haematuria
0%
Cardiac arrest
0%
Cardiopulmonary failure
0%
Haematemesis
0%
Diverticulitis
0%
Bacteraemia
0%
Fall
0%
Oropharyngeal pain
0%
Limbic encephalitis
0%
Colitis
0%
Keratitis
0%
Toxic encephalopathy
0%
Urosepsis
0%
Peripheral motor neuropathy
0%
Cardiac failure
0%
Proctitis
0%
Neurogenic bladder
0%
Gastroenteritis
0%
Pain
0%
Pneumonia aspiration
0%
Bronchitis
0%
Pleural effusion
0%
Peripheral artery occlusion
0%
Atypical pneumonia
0%
Myositis
0%
Paracancerous pneumonia
0%
Autoimmune uveitis
0%
Respiratory failure
0%
Herpes zoster
0%
Oesophagitis
0%
Vena cava thrombosis
0%
Influenza
0%
Presyncope
0%
Hyperglycaemia
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab + Etoposide ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

1 Treatment Group

Prostate Cancer
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Prostate Cancer
Drug
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at the end of study completion, an average of 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at the end of study completion, an average of 3 years for reporting.

Closest Location

CHU de Québec-Université Laval - Québec, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received newly diagnosed for Prostate Cancer or the other condition listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Cancer that has not spread to other parts of the body and that is found in the prostate gland with certain features on a tissue sample exam show original
The patient has a prostate cancer with a maximum standardized uptake value (SUVmax) of ≥4 at 18-FDG-PET/CT exam. show original
Adequate organ function
A person who is male and 18 years or older. show original
This patient is eligible to have radical prostatectomy, but there is a delay of 6 to 9 weeks. show original
Not be castrated or under androgen deprivation therapy
The patients had not received prior neo adjuvant hormonotherapy. show original
I have a tumor on my prostate that has not been irradiated. show original
The patient's performance status is 0 to 1, which means they are able to carry out normal activities. show original

Patient Q&A Section

What is prostate cancer?

"With regards to the term 'prostatistix’, there has been some controversy between the American Urology Association and the International Continence Society on one hand, and the Joint Committee on Tumor Markers and International Union Against Cancer on the other hand. The current definition recommends the use of Prostate-specific antigen (PSA) or a combination of prostate specific antigen with digital rectal examination and total PSA as a means of detection, which has been adopted by the Centers for Disease Control and Prevention (CDC) and as of April 2003 by the NWHH. A proposal for a revision is pending review by the International Continence Society and Joint Committee on Tumor Markers." - Anonymous Online Contributor

Unverified Answer

How many people get prostate cancer a year in the United States?

"At least 20 million people in the US are affected by prostate cancer at any one time. The incidence rate of prostate cancer in men ≥ 55 seems to be increasing and warrants further investigation." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Prostate cancer cannot be cured. However some men, especially those with early-stage localized disease, can do well with treatment. Survival and quality of life can be improved dramatically with early treatment. It is important to discuss the issues of curability with patients at diagnosis." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"Factors that are believed to cause [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are sexual dysfunction, diet, occupation, family history, an early age at start of regular intercourse, and a history of having a high-risk genotype for prostate cancer. Some of these factors are related to lifestyle factors and others are not. A high-fat diet is also suspected of increase the prostate cancer risk." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Coughing, coughing fits, sneezing and chest discomfort are all suggestive of prostate cancer. There are five other important signs of prostate cancer. This includes unexplained rapid weight loss, unexplained genital pain or irritation, lower urinary tract symptoms, urinary retention, fever, or unintentional urine loss from the bladder (hematuria). People with those signs should be referred urgently to an urologist." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"Prostatitis is the most common benign cause of prostate symptoms in men. If symptoms persist after the treatment of the prostate cancer or when they are recurrent following treatment, the diagnosis of acute prostatitis should be considered. There are multiple treatment options including medical care alone or in combination with nonsteroidal anti-inflammatory drugs, such as ibuprofen. Antibiotics may be used together with NSAIDs to treat acute prostatitis. There are no single treatments considered to be the gold standard." - Anonymous Online Contributor

Unverified Answer

Has pembrolizumab proven to be more effective than a placebo?

"In the randomized, phase III trial, pembrolizumab showed efficacy in preventing recurrence after radiotherapy in patients with post-prostatectomy progressive disease. Pembrolizumab did not shorten the overall survival duration after radical prostatectomy, nor did it decrease the radiotherapy doses required to achieve the optimal therapeutic ratio of radiation. However, the data obtained from the phase III study suggest a trend of efficacy in preventing second radiotherapy in the event of late progression and prolonging the overall survival duration; further studies are required to elucidate the possible effects of pembrolizumab in preventing the late progression of prostate cancer in patients with a positive surgical margin." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"Clinical trials for metastatic prostate cancer may benefit patients at all stages of clinical progression. Therefore, clinical trials should be considered as a treatment option for men with metastatic disease at diagnosis and for men with an indolent but progressive disease who do not respond to standard treatments, but the clinical benefit of such trials is still under assessment." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pembrolizumab?

"This is the first study to evaluate the efficacy and safety profile of this anti-PD-1 therapy in patients with advanced cancer. In conclusion, the results showed a significant improvement in patients with metastatic prostate cancer, metastatic melanoma and head and neck cancer who were treated with pembrolizumab and metronomic platinum-based chemotherapy. In those patients who had progressive disease, a significant improvement in survival was also witnessed." - Anonymous Online Contributor

Unverified Answer

How quickly does prostate cancer spread?

"From all prostate biopsies with > 5% cancer, only 37.7% showed local cancer spread (lymph node, distant metastasis) within the prostatic gland. Thus, prostate biopsy is insufficient to evaluate patients with a positive prostate cancer biopsy, especially if there are signs of local disease (lymph node or distant metastasis). The clinical relevance of this study should be further assessed by a prospective randomized study, comparing a more aggressive biopsy management with a less aggressive management in patients with prostate cancer diagnosed on prostate biopsy." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostate cancer?

"It is found that a relatively small percentage of young men develop [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), however there are still concerns and discussions related to this and many other aspects of prostate health. Given the number of men in the United States annually treated for benign prostatic hypertrophy, these are major uncertainties with regard to patient education and prostate health management. Given these uncertainties, it is important for health professionals to be aware of these issues." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

"It is suggested that in modern medicine, the [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) may be effectively treated only in some patients, using the following combination of treatments: an initial course of therapy on the basis of clinical and pathological examination; a course of radical prostatectomy; subsequent adjuvant therapy; periodic observation; no prophylactic treatment. After radical prostatectomy, it is advised to pay more attention to the patients' sexual function, quality of life and hormonal status than to the PSA level. It is advisable to have the possibility of performing a salvage prostatectomy if the PSA remains high or metastasizing disease is detected." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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