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Testosterone + Enzalutamide for Prostate Cancer
Study Summary
This trial is testing a new treatment for men with prostate cancer that has progressed even after other treatments. The new treatment is a combination of high dose testosterone and Enzalutamide, and the goal is to see if it is better than the standard treatment (just Enzalutamide) at improving the primary and secondary objectives.
- Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 92 Patients • NCT01275365Awards & Highlights
Trial Design
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- Your cancer has spread to certain areas that could be dangerous if treated with testosterone. For example, if you have cancer in your bones or liver that could cause fractures or compression of your spinal cord.You have a serious medical, mental, or other condition that could make it unsafe for you to participate in the study or understand what it involves.You have severe pain from prostate cancer that needs to be treated with medication.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
- Group 1: Arm C: Variable Sequential Testosterone and Enzalutamide
- Group 2: Arm B: Sequential Testosterone and Enzalutamide
- Group 3: Arm A: Enzalutamide
Frequently Asked Questions
What do medical professionals use testosterone enanthate to help patients with?
"Although typically used to treat multiple sclerosis, Testosterone enanthate can also be helpful in managing leukemia, myelocytic, acute, retinoblastoma, and histiocytic lymphoma."
Are researchers still working to enroll new participants for this trial?
"That is correct. The trial, which was first posted on 8/19/2020, is still looking for participants. The listing on clinicaltrials.gov was edited on 8/4/2022. They are looking for 150 people total at 1 site."
Could you tell me if the age limit for participants in this experiment is 35 years or younger?
"To be eligible for this study, potential participants must fall in the age range of 18 to 90. There are 361 other trials for people under the age of 18 and 2029 for people over the age of 65."
Has the FDA green-lit Testosterone enanthate for public use?
"While Phase 2 trials have not yet gathered data to support efficacy, the safety data that does exist rates Testosterone enanthate at a 2 on our scale."
What is the maximum amount of people that can take part in this experiment?
"Yes, as of 8/4/2022 this clinical study is recruiting patients. According to the listing on clinicaltrials.gov, the first posting was on 8/19/2020. They are looking for a total of 150 patients from 1 site."
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