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Hormone Therapy + Medications for Prostate Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may 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.Trial Design
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Who is running the clinical trial?
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- My liver, kidneys, and bone marrow are functioning well.My primary tumor cannot be surgically removed.I can swallow pills without any difficulty.My prostate cancer has a Gleason score of 7 and an Oncotype score over 40.I have had treatment for prostate cancer but may still qualify for a specific study group.I have been on hormone therapy for prostate cancer for up to 2 months.I have a history of inflammatory bowel disease.My liver is not working well.My cancer's stage was confirmed within the last 3 months.My metastases have been confirmed by a biopsy, if it was safe and possible.I have had issues with my pituitary or adrenal glands.I am a man aged 18 or older.My prostate cancer is confirmed by a biopsy.My prostate cancer is aggressive, based on Gleason score and tumor size.I haven't taken any forbidden medications in the last 14 days.I have been treated with medications targeting the AR signaling pathway.My cancer has spread to my brain, liver, lungs, or other internal organs.I have had treatments targeting the spread of my prostate cancer.I have a serious heart condition.My testosterone level is at least 150 ng/dL or I'm on ADT for my treatment.My cancer has recently spread but only to a few places.My prostate cancer came back after surgery, as shown on a PSMA PET scan.I am fully active and can carry on all my pre-disease activities without restriction.I have another active cancer or was diagnosed with cancer in the last 2 years.I am willing to take abiraterone acetate without eating.I need to take more than 10 mg of prednisone or prednisolone daily for a chronic condition.I have received chemotherapy or biological therapy for prostate cancer.I have recovered from my last surgery and it's been at least 4 weeks since.I have a history of seizures or conditions that could lead to seizures.My diabetes is not well-controlled.
- 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 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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