Pembrolizumab for Prostate Cancer

2
Effectiveness
3
Safety
Comprehensive Cancer Centers of Nevada ( Site 0092), Las Vegas, NV
Prostate Cancer
Pembrolizumab - Biological
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

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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 3 primary outcomes and 13 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Up to approximately 29 months.

Month 29
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
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
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 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 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
Month 40
Duration of Response (DOR)
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)
Overall Survival (OS)
Radiographic Progression-Free Survival (rPFS)
Time to First Symptomatic Skeletal-Related Event (SSRE)
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Time to Pain Progression (TTPP)
Time to Prostate-Specific Antigen (PSA) Progression
Time to Radiographic Soft Tissue Progression

Trial Safety

Safety Estimate

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

Trial Design

2 Treatment Groups

Abiraterone + Prednisone or Enzalutamide
Pembrolizumab + Olaparib

This trial requires 793 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. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Pembrolizumab + OlaparibParticipants receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
Abiraterone + Prednisone or EnzalutamideParticipants receive abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone 10 mg as one 5 mg tablet BID until progression OR Participants receive enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 40 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 40 months for reporting.

Closest Location

Comprehensive Cancer Centers of Nevada ( Site 0092) - Las Vegas, NV

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 receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before screening
Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI)
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has received prior treatment with abiraterone acetate OR enzalutamide, but not both
Have disease that progressed during or after treatment with abiraterone acetate for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression)
Participants that received abiraterone acetate for mHSPC may not have received abiraterone acetate or enzalutamide for mCRPC
Have received docetaxel chemotherapy regimen for mCRPC and have had progressive disease during or after treatment with docetaxel
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, must have been receiving stable doses before randomization
Must agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic

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 common treatments for prostate cancer?

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A range of treatment options exist for men with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). Physicians will need to do a good job of balancing the risks and benefits of the different treatments to ensure that the patient's best chance of cancer curability will prevail.

Unverified Answer

What causes prostate cancer?

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There is evidence that sex hormones can affect [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) incidence. Some studies show it is more common in males with enlarged prostates. And there is also an age-related increase in incidence of this cancer, especially in men over the age of 65. Some of these factors may be the cause of prostatic cancer.

Unverified Answer

What are the signs of prostate cancer?

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As there are no clear signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), biopsy is likely to be the first step. Screening men for serum prostate specific antigen (PSA) may help to detect a small early cancer as it has a slightly higher percentage in detecting prostate cancer than serum PSA. It is more common for a large cancer with the potential for metastasis to cause symptoms of BPH. Screening men may also want to consider a baseline PSA to check for a change in their baseline PSA levels. Screening is not a primary choice for men with an elevated risk of prostate cancer only a referral for biopsy.

Unverified Answer

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

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Almost 200,000 men and women in the United States were diagnosed with prostate cancer yearly. The proportion of younger men with prostate cancer continues to increase.

Unverified Answer

What is prostate cancer?

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Prostate cancer, though an uncommon disease, is an important health concern for all men as the disease progressively worsens. Treatment is commonly complex and involves both radical curative procedures and non-curative treatment that provides relief from symptoms and delays the onset of and/or slows the progression of prostate cancer. The American Cancer Society estimates that there will be 233,680 new cases of prostate cancer and 68,740 deaths from prostate cancer in the USA in 2011. In contrast to this, prostate cancer has the lowest survival rate among all tumours in the male population, with 10-year survival rates of 67.5% in Canada, 43.5% in the UK, 29.5% in Sweden, and a 28.

Unverified Answer

Can prostate cancer be cured?

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Although there is no evidence as yet that prostate cancer can be cured, prostate cancer is highly treatable. Treatment options are improving and some symptoms can be minimized.

Unverified Answer

Have there been any new discoveries for treating prostate cancer?

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The most effective strategy may be in early stages of prostate cancer. The role of chemotherapy remains unresolved; however, and a combination of chemotherapy and radiation therapies may be the next level of treatment for localized prostate cancer.

Unverified Answer

Is pembrolizumab typically used in combination with any other treatments?

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The majority of patients use pembrolizumab in combination with other treatments. Nevertheless, further studies are needed to identify the most appropriate patients for this treatment.

Unverified Answer

What is the latest research for prostate cancer?

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Current research shows that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) cells are constantly evolving and rearranging their receptors and other proteins to enable them to survive in our bodies. To that end, the prostate cancers have developed a ‘self’ immune system to ensure their own growth. It is for this reason that the immune system can no longer destroy the cancer cells but needs to control their growth. A new research line into the immune system's mechanisms of regulating prostate cancer growth. Prostate Cancer Suppressors. Gene Therapy. Prostate Cancer Therapeutics.

Unverified Answer

What are the latest developments in pembrolizumab for therapeutic use?

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Pembrolizumab has been shown to be an effective therapeutic option in advanced or metastatic castration-resistant disease. The efficacy and safety of pembrolizumab in men with mCRPC were similar to those reported for the treatment of mCRPC with chemotherapy (chemoradiation). Findings from a recent study provide valuable support for the inclusion of pembrolizumab in the treatment algorithm for patients with mCRPC.

Unverified Answer

What is the survival rate for prostate cancer?

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Survival probability decreased in the last decade, because the mortality from prostate cancer increased and the cause of death shifted from the prostate cancer, to the heart. Most prostate cancer deaths occurred during and/or after prostate cancer treatment, which usually affects patients with good prognosis.

Unverified Answer

What does pembrolizumab usually treat?

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Pembrolizumab is effective in the treatment of unresectable locally advanced or metastatic adenocarcinoma. In patients with mCRC, treatment with pembrolizumab leads to a short-term response at least in the majority of patients. However, OS rates remain low.

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