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Antiandrogen Therapy + SBRT for Metastatic Prostate Cancer
Study Summary
This trial is testing a combination of drugs and radiation to treat prostate cancer that has come back and spread. The drugs work in different ways to stop the growth of cancer cells, and the radiation is delivered with high precision to kill the tumor cells.
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.Side effects data
From 2021 Phase 2 trial • 86 Patients • NCT03279250Trial Design
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Who is running the clinical trial?
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- My cancer spread can be treated with targeted radiation.I have a digestive condition that affects how my body absorbs food.I have 1 to 5 visible metastases detected by a special scan.My pelvic lymph nodes are affected, but none are larger than 2 cm.My cancer has spread to nearby tissues or lymph nodes.I have been diagnosed with prostate cancer, not primarily small cell, but surgery was done.I am fully active or restricted in physically strenuous activity but can do light work.I have inflammatory bowel disease or an active connective tissue disorder.My platelet count is at least 100,000 without transfusions in the last 3 months.I am physically fit for targeted radiation therapy and hormone therapy.My testosterone level was above 150 ng/dL before starting hormone therapy.I cannot have radiotherapy or hormone therapy.I am not taking strong medications that affect liver enzyme activity.My liver function is moderately to severely impaired.My cancer has not spread to my internal organs.I stopped taking any medication that could increase my risk of seizures 4 weeks ago.I take more than 10 mg of prednisone or similar daily for a chronic condition.I have a history of seizures or conditions that could lead to seizures.I haven't had serious heart issues or blood clots in the last 6 months.My blood pressure is currently not under control.I have no other cancers except for minor skin or bladder cancers.I am taking medication that is sensitive to changes in my body's enzyme levels.I have had radiation therapy in the pelvic area, but not for prostate cancer.A biopsy of my cancer spread was attempted unless it was unsafe.My prostate cancer is primarily small cell or has neuroendocrine features.I do not have an active infection like HIV or hepatitis.I have signs of pressure on my spinal cord.I have had cancer in my pelvic area before.My cancer has spread to my internal organs.
- Group 1: Treatment (leuprolide, apalutamide, abiraterone acetate, SBRT)
- 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
What particular medical condition is Apalutamide commonly prescribed to treat?
"Apalutamide is often prescribed to tackle the symptoms of cervical syndrome, but it may also prove beneficial in managing minor burns, non-metastatic prostate cancer, and for patients who have undergone a transplant."
What health risks are associated with Apalutamide?
"Our team's assessment of Apalutamide's safety is a 2, as this drug has only been tested in Phase 2 trials. This affirms that there is some evidence for the medication's security even though its efficacy remains unconfirmed."
Are there any opportunities for participation in this clinical trial currently available?
"Clinicaltrials.gov confirms that this clinical trial is looking for participants, with the experiment first listed on March 17th 2021 and given an update as recently as August 9th 2022."
Are there any prior investigations into Apalutamide's efficacy?
"Currently, there are 274 separate studies assessing the efficacy of Apalutamide. Of those trials, 79 have entered into Phase 3 and 12185 investigative sites exist worldwide to evaluate this medication's benefits. In particular, many of these clinical trials are based in Duarte, California."
Are there limitations to the number of participants in this medical experiment?
"Indeed, the data available on clinicaltrials.gov reveals that this medical experiment is currently accepting participants. First posted on March 17th 2021, it was last modified on August 9th 2022 and 28 people are being sought from a single research clinic."
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