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Antiandrogen
Combination Therapy for Prostate Cancer
Phase 1
Waitlist Available
Led By Robert Den, MD
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease
Age > 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 year
Awards & highlights
Study Summary
This trial is testing a combination of therapies to treat prostate cancer.
Who is the study for?
Men over 18 with intermediate or high-risk prostate cancer that hasn't spread far (no distant metastases), a Gleason score ≥7, PSA ≥10 ng/ml, or T2b+ disease. They must have good organ function and blood counts, be able to use contraception, and not have had certain treatments or conditions that could complicate the trial.Check my eligibility
What is being tested?
This phase I trial is testing how well patients tolerate combining enzalutamide with radiation therapy and hormone therapy using leuprolide acetate or goserelin acetate. The goal is to see if this combination can effectively treat prostate cancer by reducing the body's production of androgens.See study design
What are the potential side effects?
Possible side effects include fatigue, hot flashes, sexual dysfunction, urinary issues due to radiation therapy; plus any potential risks from enzalutamide like seizures, liver changes, blood pressure increases, and mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer has not spread, with a high Gleason score, PSA level, or is T2b or greater.
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I am older than 18 years.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria
Secondary outcome measures
Change in PSA levels
Quality of life (QoL), measured using the EPIC, AUA symptom index, and the PROMIS Fatigue Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (enzalutamide, radiation therapy, hormone therapy)Experimental Treatment4 Interventions
Patients receive enzalutamide PO QD for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate SC or leuprolide acetate IM or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH therapy, patients undergo either IMRT or VMAT daily five days a week for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved
Goserelin
FDA approved
Radiation therapy
2013
Completed Phase 3
~2850
Enzalutamide
FDA approved
Find a Location
Who is running the clinical trial?
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,189 Total Patients Enrolled
36 Trials studying Prostate Cancer
8,642 Patients Enrolled for Prostate Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,217 Total Patients Enrolled
12 Trials studying Prostate Cancer
668 Patients Enrolled for Prostate Cancer
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,886 Total Patients Enrolled
13 Trials studying Prostate Cancer
1,567 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during and for 3 months after treatment.I have a history of lower GI issues that could worsen with radiation.I am not taking itraconazole or similar medications.My prostate cancer has not spread, with a high Gleason score, PSA level, or is T2b or greater.I am older than 18 years.My liver is working properly.I have had seizures or brain-related health issues in the past year.My cancer has spread to distant parts of my body, but it may include pelvic lymph nodes.I am currently taking specific medications.I have had surgery or procedures on my urinary system that may cause complications after radiation.I am not taking any medications that speed up drug breakdown.I have had surgery or cryosurgery for prostate cancer or both testicles removed.I am fully active or can carry out light work.I haven't had any cancer except skin cancer in the last 5 years.I have had chemotherapy or radiation to the pelvis before.I am not taking medications like Gemfibrozil.I am not taking medications like rifampin.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enzalutamide, radiation therapy, hormone therapy)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
What is the scope of enrollment for this clinical trial?
"At this time, no further individuals are being accepted for the clinical trial that was posted on April 2nd 2014. However, if you seek alternatives to enroll in a medical study, 1259 trials require participants with stage IV prostate cancer and there are 185 studies currently accepting Leuprolide acetate patients."
Answered by AI
Is this research endeavor presently seeking participants?
"Clinicaltrials.gov affirms that this clinical trial, first posted on April 2nd 2014 and last updated on August 15th 2022, is no longer recruiting patients. However, there are currently 1444 other medical trials actively looking for participants."
Answered by AI
To what extent has Leuprolide acetate been explored in research endeavours?
"Currently, 185 clinical trials are assessing the efficacy of Leuprolide acetate. Of these studies, 59 have reached Phase 3 and are being conducted at 12458 sites with a concentration in Germantown, Tennessee."
Answered by AI
Does this trial present any untested interventions?
"Presently, there are 185 live studies involving Leuprolide acetate in 59 different countries. The initial clinical trial for this drug was conducted by AstraZeneca in 2000 with 600 participants and concluded its Phase 3 approval stage successfully. Since that time, a total of 334 trials have been completed."
Answered by AI
What medical conditions are typically addressed with leuprolide acetate?
"Leuprolide acetate can be used to treat a variety of ailments, including breast cancer, radiation therapy-related side effects, and endometrial thinning."
Answered by AI
Has Leuprolide acetate been verified by the FDA?
"Due to its early phase 1 status, our team at Power only awarded Leuprolide acetate a score of one out of three on the safety scale. This is because there are limited data proving both efficacy and protection."
Answered by AI
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