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Immunotherapy + Hormone Therapy for Prostate Cancer (Neo-Red-P Trial)
Neo-Red-P Trial Summary
This trial is testing whether adding immunotherapy to degarelix, which suppresses testosterone, can decrease the chance cancer will come back after surgery, compared to degarelix alone.
Neo-Red-P Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNeo-Red-P Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Neo-Red-P Trial Design
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Who is running the clinical trial?
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- I am mostly active and can care for myself.I am 18 years old or older.I do not have any serious heart conditions.My prostate cancer is not the usual type.I have taken steroids for less than 5 days within the last week.You have had a severe allergic reaction to a specific type of medication called a monoclonal antibody.I have not had a heart attack or stroke in the last 6 months.I am scheduled for a major prostate surgery at Columbia University Irving Medical Center.I have a serious heart condition, such as heart failure or cardiomyopathy.My cancer has spread to lymph nodes or other parts of my body.My prostate cancer is confirmed and has not spread to lymph nodes or other organs.My initial prostate biopsy shows at least 2 positive cores with a Gleason score of 7 or higher.I haven't had cancer in the past 2 years, except for skin or superficial bladder cancer.My thyroid condition is stable now.You had eczema as a child, but it's no longer a problem for you.I have vitiligo.I need daily oxygen therapy due to heart disease.I have not had an infection in the last week.My liver, kidneys, and bone marrow are working well.I have not received a live vaccine in the last 30 days.I agree to use barrier contraception during and up to 165 days after my treatment.I haven't taken high doses of steroids or immunosuppressants in the last 14 days.I am not currently on hormonal therapy or taking medication to reduce prostate gland size.I have received treatments like radiation, hormone therapy, or chemotherapy for prostate cancer.I have a history of serious heart rhythm problems.I have a history of HIV.My psoriasis hasn't needed systemic treatment in the last 2 years.I have received immunotherapy or vaccine therapy for prostate cancer.I have had myocarditis in the past.I have not had unstable chest pain in the last 3 months.
- Group 1: Safety lead-in
- Group 2: Arm A
- Group 3: Arm B
- 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 prior experiments have there been concerning the use of BMS-986218 and Degarelix?
"Currently, there are 31 active trials assessing the efficacy and safety of BMS-986218 and Degarelix with 8 being at Phase 3. Although many clinical studies for these drugs are located in Los Angeles, California; other sites across the country - totalling 1481 locations - have ongoing activities related to them."
What is the scope of participants in this clinical experiment?
"Affirmative. The clinicaltrials.gov website attests that this medical investigation is currently enrolling volunteers, having been uploaded on February 25th 2020 and updated as recently as October 27th 2021. This study requires 24 participants from a single location to complete the trial."
Is this the inaugural study of its type?
"Since its initial clinical trial, sponsored by Ferring Pharmaceuticals in 2012 and involving 41 patients, BMS-986218 and Degarelix has seen tremendous research. Subsequently receiving N/A drug approval, the medication is now being examined through 31 distinct trials conducted across 14 nations in 563 cities."
Are there still positions available to join this clinical experiment?
"Clinicaltrials.gov indicates that registration for this medical trial, which was first launched on February 25th 2020, is still open and recruiting patients. The latest report of the study's progress was posted on October 27 2021."
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