Pembrolizumab for Prostate Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
Biomelab S A S ( Site 1067), Barranquilla, Colombia
Prostate Cancer
Pembrolizumab - Biological
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)

See full description

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 10 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to approximately 28 months.

Month 28
Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience an Adverse Event (AE)
Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
Overall Survival (OS)
Prostate-specific Antigen (PSA) Response Rate
Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
Time to First Symptomatic Skeletal-related Event (SSRE)
Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)
Time to Prostate-specific Antigen (PSA) Progression
Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo+Docetaxel
Pembrolizumab+Docetaxel
Placebo group

This trial requires 1000 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Pembrolizumab+DocetaxelOn Day 1 of each 21-day cycle, participants receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours and 1 hour prior to docetaxel administration PLUS docetaxel 75 mg/m^2 by intravenous (IV) infusion for up to a maximum of 10 cycles (approximately 7 months). Participants receive prednisone 5 mg by oral tablets twice daily during each docetaxel cycle up to a maximum of 10 cycles (approximately 7 months). Participants also receive pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for up to a maximum of 35 cycles (approximately 2 years).
Placebo+DocetaxelOn Day 1 of each 21-day cycle, participants receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours and 1 hour prior to docetaxel administration PLUS docetaxel 75 mg/m^2 by IV infusion for up to a maximum of 10 cycles (approximately 7 months). Participants receive prednisone 5 mg by oral tablets twice daily during each docetaxel cycle up to a maximum of 10 cycles (approximately 7 months). Participants also receive placebo by IV infusion on day 1 of each 21-day cycle for up to a maximum of 35 cycles (approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Docetaxel
FDA approved
Dexamethasone
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 28 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 28 months for reporting.

Closest Location

Georgia Cancer Center at Augusta University ( Site 0026) - Augusta, GA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)

Patient Q&A Section

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

What is prostate cancer?

Add answer

It can be said that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is a multifocal disease, with an unknown number of possible primary sites. The probability of getting the disease from a prostate biopsy must be taken into account in both research and clinical practice. It is probable that some of the tumours in the prostate were a result of exposure during the life, including the first period of male life.

Unverified Answer

What are common treatments for prostate cancer?

Add answer

Patients treated for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) may be treated a number of different ways, depending on a variety of factors from patient to patient.\n\nThe National Cancer Institute"

"Umbiliconia\n\nUmbiliconia is a genus of flowering plants in the family Annonaceae.

Unverified Answer

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

Add answer

The American Cancer Society estimates that an estimated 250,000 people will be diagnosed with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in 2022 in the United States. In 2003, the estimated number of new American deaths from prostate carcinoma was 39,300; approximately 75,000 new cases of prostate cancer are diagnosed in the United States each year.

Unverified Answer

What causes prostate cancer?

Add answer

There are many causes, but the single biggest risk factor contributing to [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is age and the second largest risk factor is smoking. While smoking is the single biggest risk factor for non-prostate cancer, this is true for prostate cancer as well. In addition, there have been several reports showing that prostate cancer is more likely to manifest in people with a family history of the disease. There are a wide array of other risk factors that add to prostate cancer, but none in any significant way. A key limitation of research is that most prostate cancer occurs too late in life for earlier identification in a clinical setting and research. For better prediction, and potentially for better prevention, a better understanding of the etiology of prostate cancer is needed.

Unverified Answer

Can prostate cancer be cured?

Add answer

A cure for prostate cancer is not achievable. For some men, the burden from treatment and other comorbidities may outweigh the benefit of potential cure, and prostate cancer remains an integral part of their medical care and life.

Unverified Answer

What are the signs of prostate cancer?

Add answer

The symptoms of prostatitis are similar regardless of the histological sub-type of the prostate cancer. Histological sub-type, tumor morphology (GPS and stage) and Gleason score is associated with PSA level. The findings on MRI are associated, however, with PSA. The combination of these three factors, such as tumour morphology and disease stage, has diagnostic and prognostic value.

Unverified Answer

How quickly does prostate cancer spread?

Add answer

The rate of spread is not clear-cut from autopsy. Histologically defined stage T3 prostate cancer in autopsy specimens is less than 20% of all cases. We consider the T status of 10% as being an acceptable margin of error to predict the disease in all patients who are diagnosed clinically.

Unverified Answer

What does pembrolizumab usually treat?

Add answer

Although the benefit of pembrolizumab in patients with metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (≥ 50% staining) is well established and has become a widely accepted treatment, the role of pembrolizumab in patients with metastatic prostate cancer (mPCa) has more nuanced. The role of pembrolizumab in mPCa has not been clearly defined. As of now the role of pembrolizumab has been investigated only in patients failing standard of care therapy for advanced prostate cancer patients with metastatic bone disease.

Unverified Answer

Who should consider clinical trials for prostate cancer?

Add answer

With an increasing number of high sensitivity cancer registries (HSCR), a significant number of patients with clinically insignificant prostate cancer (pT1a/b) may be detected in an ongoing clinical trial. Given their lower risk of progression, patients with such early prostate cancer should be considered as candidates for clinical trials. A substantial proportion of patients with clinically significant cancer (pT2) may also be eligible for clinical trials.

Unverified Answer

How does pembrolizumab work?

Add answer

In this first-ever-reported report, pembrolizumab in combination with androgen deprivation provided a significant clinical benefit in men with metastatic castration-resistant prostate cancer. However, pembrolizumab-associated toxicity must be carefully evaluated as no conclusive predictive factors for toxicity were identified.

Unverified Answer

Does prostate cancer run in families?

Add answer

These data suggest that prostate cancer susceptibility does not run in families. This is in contrast to colorectal cancer, which shows that it is a heritable disease.

Unverified Answer

What is the latest research for prostate cancer?

Add answer

The prostate cancer research is not new because it is a big part of most new developments in medicine. In our review, we summarize the latest and most interesting research about prostate cancer. We hope that this will help the reader to understand current research about prostate cancer better.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Prostate Cancer by sharing your contact details with the study coordinator.