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Hormone Therapy
ADT + Docetaxel + Enzalutamide for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Earle Burgess, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver function: AST and ALT <1.5x upper limit of normal, total bilirubin < 1x upper limit of normal
Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation with metastatic disease present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study participation, an average of 2-3 years
Awards & highlights
Study Summary
This trial is testing a new prostate cancer treatment that may be more effective than the current standard of care.
Who is the study for?
Men aged 18+ with metastatic prostate cancer, a PSA level of ≥5 ng/ml, and good performance status (ECOG 0-2) can join. They should have started hormone therapy recently or had it before for non-metastatic disease. Participants need proper liver, kidney, and bone marrow function and must be able to take oral meds. Those with severe neuropathy, active infections like HIV or hepatitis B/C, recent heart issues, another active cancer within the last year, conditions that could cause seizures or affect drug absorption are excluded.Check my eligibility
What is being tested?
The trial is testing if combining hormone therapy (ADT), chemotherapy (docetaxel), and a targeted drug (enzalutamide) works better for advanced prostate cancer than just ADT with chemo. It's checking how well patients tolerate this mix and if it improves their condition.See study design
What are the potential side effects?
Possible side effects include fatigue; digestive problems like nausea; skin reactions; blood disorders such as low red/white cell counts; hormonal changes causing hot flashes or sexual dysfunction; nerve issues leading to numbness or tingling in hands/feet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver tests are within normal limits.
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My prostate cancer has spread and is not mainly neuroendocrine or small cell type.
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I started hormone therapy for cancer less than 112 days ago.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
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My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.
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I can take pills and keep them down.
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My blood tests show enough platelets, hemoglobin, and white blood cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study participation, an average of 2-3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study participation, an average of 2-3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
52-week PSA Complete Response (CR) Rate
Secondary outcome measures
Overall Survival
Radiographic Progression Free Survival
Radiographic Response Rate
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Docetaxel + Enzalutamide + Androgen Deprivation Therapy
Find a Location
Who is running the clinical trial?
Earle Burgess, MDLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,197 Total Patients Enrolled
20 Trials studying Prostate Cancer
1,729 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
232,174 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,602 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV or active hepatitis B or C.I haven't had a heart attack, severe chest pain, heart surgery, heart failure, or stroke in the last 3 months.I have not had any other cancer besides this one in the last year.My liver tests are within normal limits.My prostate cancer has spread and is not mainly neuroendocrine or small cell type.I started hormone therapy for cancer less than 112 days ago.I am 18 years old or older.I can take care of myself and perform daily activities.My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.I have been taking more than 10mg of prednisone daily for over two weeks.I can take pills and keep them down.My cancer has spread to my brain or its coverings.I have a condition that affects how my body absorbs medication.I have been treated with specific prostate cancer or chemotherapy drugs.I haven't had major surgery in the last 28 days or still recovering from one.I have had a condition where swelling occurs in the brain.I experience moderate to severe numbness or tingling in my hands or feet.I am currently taking medication that strongly affects liver enzyme activity.I do not have any uncontrolled illnesses or infections that would stop me from following the study's requirements.My blood tests show enough platelets, hemoglobin, and white blood cells.I have had a seizure before.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 number of individuals taking part in this experiment?
"At the moment, this research project is not looking for participants. It was first made available on August 21st 2017 and last updated June 1st 2022. However, if you are trying to find other trials related to prostate cancer there are 1341 active studies as well as 403 ADT+Docetaxel+Enzalutamide clinical trials taking part in recruitment efforts."
Answered by AI
Is there still capacity in this trial for new participants?
"Unfortunately, patient recruitment for this trial is no longer available. Initially posted in August 2017, the last update was on June 1st 2022. However there are 1341 trials recruiting prostate cancer patients and 403 studies enrolling participants to test a combination of ADT+Docetaxel+Enzalutamide therapy."
Answered by AI
Has the utilization of ADT+Docetaxel+Enzalutamide been authenticated by the Food and Drug Administration?
"As a Phase 2 trial, there is sufficient evidence to rate the safety of ADT+Docetaxel+Enzalutamide at a moderate level of 2 on our scale. Although data affirms its security, no proof exists yet that it functions as an efficacious treatment."
Answered by AI
To what medical issues is the combination of ADT+Docetaxel+Enzalutamide typically applied?
"ADT+Docetaxel+Enzalutamide is frequently taken to treat malignant tumours. Additionally, this medication can be prescribed for advanced directives, sarcoma and esophageal neoplasms of a cancerous nature."
Answered by AI
Have researchers conducted prior studies with the combined use of ADT, Docetaxel, and Enzalutamide?
"Presently, there are 403 active studies being conducted in regards to ADT+Docetaxel+Enzalutamide with 150 of them belonging to Phase 3. Most of these trials are taking place Germantown, Tennessee but globally 27511 medical centres are running clinical trials for ADT+Docetaxel+Enzalutamide."
Answered by AI
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