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Study Summary
This trial is testing if treatment with medications that reduce the male hormone level can shrink prostate cancer and reduce the chances of the cancer coming back. The treatments include a hormone injection and the study drugs, which include abiraterone acetate, prednisone, and apalutamide.
- 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.Awards & Highlights
Trial Design
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- You have received treatment for prostate cancer that was targeted specifically at the spread of cancer to other parts of the body.Your high blood pressure is not being managed or controlled.You are unable to have an MRI scan due to discomfort or medical reasons.You have taken medication such as ketoconazole, abiraterone acetate or enzalutamide that affect the androgen receptor signaling pathway before.You cannot be taking any other experimental medication at the same time.You have a serious heart condition.You have a history of seizures or any condition that may make you more likely to have a seizure.You have a history of chronic bowel inflammation.You have a health condition that requires you to take more than 10mg of prednisone/prednisolone per day for a long time.You are okay with taking abiraterone acetate without food.You have a history of problems with your pituitary or adrenal glands.You can swallow pills or tablets as instructed.You are allergic or intolerant to apalutamide, abiraterone acetate, prednisone, or GBRH agonist or GNRH antagonist.You have received treatment for prostate cancer in the past, except for TURP (a surgical procedure) or if your PSA levels have increased after RP (a type of surgery).If you have sex with a pregnant woman while taking the study drug, you must use both a condom and another effective method of birth control, and continue to do so for 3 months after stopping the medication.
- Group 1: Apalutamide, SBRT, Radiation
- Group 2: ADT + Apalutamide + Abiraterone Acetate + Prednisone
- Group 3: ADT + Apalutamide
- 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.
Frequently Asked Questions
Is the enrollment process for this study still available to participants?
"As detailed on clinicaltrials.gov, this medical trial is currently in need of participants and has been since June 21st 2018. The information was last refreshed on June 28th 2022."
How many sites are facilitating this research study?
"Currently, 11 clinical sites are facilitating this medical trial. These locations span from Cleveland to Harrison and Basking Ridge. To reduce the strain of travel on enrollees, potential participants should select a site closest to them."
What potential health risks are associated with Apalutamide?
"Apalutamide's safety has been documented in Phase 2 trials, so its risk score is a 2. No efficacy data exists yet to support the medication."
What health issues is Apalutamide typically employed to address?
"Apalutamide has a range of medicinal applications, from managing cases of thyroiditis to treating prostate cancer non-metastatic and malignancies. It can also be used for ulcerative colitisg prostate cancer non-metastatic and malignancies. It can also be used for ulcerative colitis relief."
How many participants can be accommodated in this clinical experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial which began its recruitment in June 2018 is still actively searching for participants. 112 individuals are needed from 11 different hospitals and clinics."
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