Pembrolizumab for Prostate Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040), São Paulo, Brazil
Prostate Cancer
Pembrolizumab - Biological
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)

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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 11 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to ~ 51 months.

Month 51
Overall Survival (OS)
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
Month 67
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
Prostate-specific Antigen (PSA) Response Rate
Prostate-specific Antigen (PSA) Undetectable Rate
Time to First Symptomatic Skeletal-related Event (SSRE)
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (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 + Enzalutamide
Pembrolizumab + Enzalutamide
Placebo group

This trial requires 1240 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 + EnzalutamideParticipants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.
Placebo + EnzalutamideParticipants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Enzalutamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~ 67 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to ~ 67 months for reporting.

Closest Location

Inova Schar Cancer Institute ( Site 0006) - Fairfax, VA

Eligibility Criteria

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

Mark “yes” if the following statements are true for you:
The main inclusion

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 are the signs of prostate cancer?

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  1. Symptoms such as lower back pain\n2. Signs of metastasis, such as bone, lymph node, or liver metastases\n3. Signs of metastases at diagnosis such as elevated prostate-specific antigen, prostate-specific membrane antigen, lymph node ratio or tumor volume\n4. Gleason grade\n5. Tumor burden, including pathological grade\n6. Recurrent disease\n7.
Unverified Answer

What causes prostate cancer?

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It is plausible that a high-protein diet and tobacco use may influence the risk of acquiring prostate cancer. However, no relationship between prostate cancer and diet was found in a multifactorial analysis performed by Kattan and colleagues.

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What is prostate cancer?

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Men suffering prostate cancer are at a high risk of dying from heart disease and stroke. It is therefore important that primary care physicians keep an eye out for signs of cardiovascular disease in their patients. Diabetes and hypertension can also be associated with an increased risk of prostate cancer.

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Can prostate cancer be cured?

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This article highlights the important, yet inconclusive, research available about possible cures for prostate cancer. However, in the short term, many men are still living with a prostate cancer diagnosis, and a cure is desperately needed.

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What are common treatments for prostate cancer?

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Different approaches are used depending on the type and progression severity of the disease. The current status of cancer in the United States is an improving one. New and exciting therapies have helped in increasing the survival rates especially in advanced cancer stages. Radiation and surgery are the standard of care for most prostate cancer. Many types of medications have been used against prostate cancer such that a treatment plan has to be generated based on the disease, the patient, and the health professionals. New medications and therapies have been approved to help prostate cancer patients. It is crucial for health professionals involved in managing the cancers, especially through cancer and its related subtypes, to keep up to date and be updated on newer cancer treatments.

Unverified Answer

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

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At least 25 million US residents were diagnosed with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) in 2000. This leads to an average of 11,000 diagnoses a year. It is also estimated that 10% of these men will have one metastatic bone disease and 50% will have one primary cancer. As such, prostate cancer remains the most common cancer diagnosed in the United States in 2000.

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What is the average age someone gets prostate cancer?

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Mean average age at time of diagnosis for prostate cancer is 66.4 ±13.2. The incidence of prostate cancer is highest in a narrow age span at 61.4–67.2. Age at diagnosis is not prognostically significant. A decrease of age at diagnosis will not solve the problem of prostate cancer as a major public health problem.

Unverified Answer

Is pembrolizumab safe for people?

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Given pembrolizumab is approved for treatment of cancer metastatic to the brain, skin and lymph nodes, it can be administered safely to people with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), as was previously found in randomized phase II or multicenter clinical trials. Prostate biopsies can be done with or without MRI as they are of no importance for treatment response.

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What is the survival rate for prostate cancer?

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At 4 and 8 years, the 5 year survival rate for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is about 77%. The survival rate over 10 years is still 60-65%. The survival rate for prostate cancer is much lower in patients who present with prostate cancer at high volume disease (i.e., cancer in half of the prostate) or more advanced stage than high volume cancer (stage T3b or higher). Prostate cancer with these higher-risk features presents many technical challenges to treatment that requires careful consideration of the risk versus the benefit.

Unverified Answer

Who should consider clinical trials for prostate cancer?

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Clinicians and men should consider a clinical trial when they have concerns about disease burden or treatment options. The use of a clinical trial is associated with positive mood. The use of a clinical trial appears to reduce men's thoughts about prostate cancer.

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What is pembrolizumab?

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Pembrolizumab has been approved by the FDA and EMA as a treatment of melanoma (among others). Its use for other cancer indications is under investigation. Pembrolizumab is currently used in conjunction with other anticancer agents for treating patients with the following diseases: melanoma, metastatic renal cell carcinoma, advanced non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and in relapsed advanced solid tumours. The drug acts by antagonizing PD-1, a receptor found primarily in tumour cells but rarely in normal cells. This property has created opportunities for cancer immunotherapy, which entails manipulating immune systems to detect and kill cancer cells.

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What is the primary cause of prostate cancer?

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The association of environmental exposures with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is not entirely clear. The contribution of these factors is not completely understood, although most likely they are complex and act simultaneously in the biologic pathways of cancer initiation and promotion.

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