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Nivolumab + Radiation + Hormone Therapy for Prostate Cancer
Study Summary
This trial is testing a new cancer drug combination to see if it is safe, works well, and delays prostate cancer progression.
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 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- I am fully active or can carry out light work.My prostate cancer is aggressive (Grade Group 5) with a high Gleason score.I have a confirmed diagnosis of prostate cancer and am starting my first treatment.I am not allergic to any of the drugs or their components used in this study.I do not have any uncontrolled illnesses like infections or heart problems.I do not have active autoimmune diseases except for controlled type I diabetes, hypothyroidism, or certain skin conditions.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I am a man aged 18 or older.I have cancer spread to 3 or fewer places and/or in pelvic lymph nodes, and am being treated to cure it.I agree to use contraception during and after the study for a total of 31 weeks if I'm sexually active with women who can get pregnant. I won't donate sperm during this time.I am receiving radiation therapy at Moffitt Cancer Center.I have lung disease that causes symptoms or could affect lung-related side effects from treatment.I had cancer before, but it's been in complete remission for over 2 years and I don't need treatment now.I tested positive for HCV antibodies but do not currently have an active infection.I have tested positive for HIV/AIDS.My blood, liver, or pancreas functions are not normal.I am eligible for specific radiation therapy and hormone treatment.My organs are functioning normally while I'm on nivolumab.I have recovered from major surgery or significant injury for at least 14 days before starting prostate radiation.I have previously received treatments targeting the immune system.
- Group 1: Combination Therapy
- 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 is the upper limit of participants that can join this trial?
"Affirmative, based on the information available at clinicaltrials.gov this research study is actively enrolling participants. It was first posted in October 3rd 2018 and last revised November 11th 2022 - with 44 patients needed to be enrolled from 1 site."
Could you please summarize the previous research conducted with Nivolumab?
"Currently, 718 clinical trials related to Nivolumab are being conducted with 82 of these studies in their final phase. The majority of the tests for this treatment take place in Zürich, but there are 40285 locations where trials can be found."
What conditions commonly necessitate the administration of Nivolumab?
"Nivolumab is widely known to treat malignant neoplasms, but also has demonstrated efficacy in treating other severe conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Does this trial offer a pioneering approach to treatment?
"Since 2012, when Ono Pharmaceutical Co. Ltd first conducted their Phase 1 & 2 study of Nivolumab with 659 participants in it, a total of 718 live studies for this drug have been launched across 2356 cities and 49 countries globally. 276 research trials dedicated to investigating the efficacy of Nivolumab have been completed since its inception."
Is recruitment of participants still occurring for this experiment?
"Affirmative. The online portal clinicaltrials.gov showcases that this medical experiment, which was first published on October 3rd 2018, is presently looking for recruits. Approximately 44 people must be enrolled from a single location."
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