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Antiandrogen
Enzalutamide for Prostate Cancer (PROSPER Trial)
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months)
Awards & highlights
PROSPER Trial Summary
This trial is testing a new drug to treat prostate cancer that has not spread. They will be testing how well it works and if it is safe.
Who is the study for?
Men with nonmetastatic, castration-resistant prostate cancer can join this trial. They must be on hormone therapy or have had surgery to lower testosterone levels, have a rising PSA level with a doubling time of 10 months or less, and no signs of the cancer spreading. Participants should be relatively healthy overall, with an expected lifespan of at least one year.Check my eligibility
What is being tested?
The study is testing Enzalutamide's effectiveness and safety against a placebo in men whose prostate cancer hasn't spread but continues to grow despite low testosterone levels. The goal is to see if Enzalutamide can help control the disease better than no treatment (placebo).See study design
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint pain, and hot flashes. It might also affect mental function leading to difficulty concentrating or memory problems. Rarely it could increase seizure risk.
PROSPER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until first psa progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until first psa progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metastasis Free Survival (MFS)
Secondary outcome measures
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Pharmacotherapy
Chemotherapy-Free Survival
+43 moreSide effects data
From 2017 Phase 4 trial • 215 Patients • NCT0211658234%
Fatigue
25%
Decreased appetite
18%
Asthenia
17%
Back pain
16%
Arthralgia
15%
Nausea
13%
Bone pain
13%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total
PROSPER Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EnzalutamideExperimental Treatment1 Intervention
160 mg by mouth once daily
Group II: PlaceboPlacebo Group1 Intervention
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,910,472 Total Patients Enrolled
41 Trials studying Prostate Cancer
10,968 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
690 Previous Clinical Trials
230,638 Total Patients Enrolled
35 Trials studying Prostate Cancer
7,241 Patients Enrolled for Prostate Cancer
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
21 Previous Clinical Trials
8,532 Total Patients Enrolled
9 Trials studying Prostate Cancer
4,179 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks.I am allergic to certain ingredients in the medication's capsule.My cancer has not spread to other parts of my body.I have brain metastasis or active leptomeningeal disease.My testosterone levels are low, at or below 50 ng/dL.I have not had another invasive cancer in the last 3 years.I have a stomach or intestine condition that affects how my body absorbs food.My cancer has worsened despite hormone therapy.I am currently on hormone therapy for cancer or have had both testicles removed.My prostate cancer is confirmed and does not have certain aggressive features.I have a serious heart condition.I have a history of seizures or conditions that could lead to seizures.My cancer has worsened despite hormone therapy.I can carry out all my daily activities without help.My cancer has not spread to other parts of my body.My prostate cancer is confirmed and does not have certain aggressive features.My prostate cancer does not cause any symptoms.I am currently on hormone therapy for cancer or have had surgery to remove my testicles.I have not used hormonal or biologic therapy for prostate cancer, except for bone agents or GnRH treatments, in the last 4 weeks.I have received chemotherapy before.I am fully active or can carry out light work.My prostate cancer does not cause any symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Enzalutamide
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being monitored in this clinical trial?
"Unfortunately, this particular clinical trial is not recruiting patients at the moment. The study was initially posted on October 31st, 2013 and was last updated on February 22nd, 2022. There are 1364 other trials related to prostate cancer that are actively enrolling patients and 103 for Enzalutamide if you wish to explore other options."
Answered by AI
Has Enzalutamide received government sanctioning for medical use?
"On a scale from 1 to 3, our team at Power estimates the safety of Enzalutamide to be a 3 because this is a Phase 3 trial."
Answered by AI
Are there other cases where Enzalutamide has been tested in a clinical setting?
"Enzalutamide was first researched in 2005 at the Rosemere Cancer Centre. Since then, there have been 18369 completed trials with 103 currently active ones. A large number of these studies are being conducted in Nashville, Tennessee."
Answered by AI
Are researchers actively looking for new participants for this clinical trial?
"This study is no longer recruiting patients. The trial was posted on October 31st, 2013 and updated for the last time on February 22nd, 2022. However, there are 1,367 other trials you may be eligible for--1364 that are actively enrolling prostate cancer patients and 103 for Enzalutamide."
Answered by AI
Could you please list how many hospitals have agreed to participate in this research project?
"53 patients are being recruited from various locations including Vanderbilt University Medical Center, The Urologic Clinic in Nashville, Vanderbilt University Medical Center, Dept. of Urologic Surgery in Montreal, and Centre Hospitalier de l'Universite de Montreal in Calgary."
Answered by AI
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