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Durvalumab + Olaparib for Prostate Cancer
Study Summary
This trial is testing the combination of two drugs, durvalumab and olaparib, to treat prostate cancer in men with specific genetic mutations.
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 2 trial • 80 Patients • NCT03015129Trial Design
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Who is running the clinical trial?
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- I have or had an autoimmune or inflammatory disorder, but it might be an exception.I am not currently on, nor have I been on cancer treatment in the last 3 weeks.My PSA is at least 2 ng/ml after radiation, or I've had a prostatectomy. My PSA doubles in 10 months or less.I either had salvage radiation before or am not suitable for it due to my health or choice.I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.My scans show no signs of cancer spread beyond the original site.I have never been treated with a PARP inhibitor like olaparib.I do not have any serious, uncontrolled health issues or infections.I am not taking strong or moderate CYP3A inhibitors.I have had cancer spread to the lining of my brain and spinal cord.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I will use a condom during and for 3 months after treatment if my partner could become pregnant.My kidneys are functioning well, with a creatinine clearance rate of at least 51 mL/min.I haven't taken immunosuppressive drugs in the last 14 days, except for specific exceptions.My cancer has specific genetic changes.I am able to understand and sign the consent form.I have had a bone marrow or cord blood transplant in the past.I had major surgery more than 2 weeks ago and have recovered.I stopped hormonal therapy over 6 months ago and my testosterone is above 150 ng/dl.My body weight is over 30 kg.I have had surgery or radiation for prostate cancer.I have had cancer before, but it fits the exceptions.My heart condition is stable and does not include uncontrolled issues or long QT syndrome.I cannot swallow pills or have stomach issues affecting medication absorption.You are expected to live for at least 16 more weeks.My prostate cancer is confirmed to be adenocarcinoma.My cancer has spread to 3 or fewer places, as shown by advanced scans.I do not have an active infection like TB or hepatitis.I am not taking any strong or moderate drugs that affect liver enzymes.I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.I am older than 18 years.I can carry out all my self-care activities without assistance.I had chemotherapy for prostate cancer more than 6 months ago, not as part of initial treatment.Your immune system is not working properly, for example, if you have uncontrolled HIV.I have previously been treated with a PD1 or PD-L1 inhibitor.I have not received a live vaccine within the last 30 days.My hemoglobin level is at least 10.0 g/dL without recent blood transfusions.You are allergic to olaparib or durvalumab, or any of the ingredients in the medication.You have participated in another research study where you were given an experimental drug within the last 3 months.
- Group 1: Treatment (durvalumab, olaparib)
- 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 are the most recent findings from other tests using Durvalumab?
"As of now, there are 497 ongoing studies investigating Durvalumab with 74 in Phase 3. While a significant number of these research projects are based in Houston, Texas; there are actually 20,974 locations conducting trials for Durvalumab."
Are we still seeking participants for this research?
"Yes, this trial is still recruiting patients according to the latest update on clinicaltrials.gov from November 8th, 2022. The initial posting was on April 13th, 2021."
Are there any dangers associated with Durvalumab treatments?
"Because Durvalumab is only in Phase 2 clinical trials, there is not yet enough evidence to support its efficacy. However, it has been deemed somewhat safe and received a score of 2."
How many people are enrolled in the research project?
"Yes, as indicated on the clinicaltrials.gov website, this study is currently looking for 30 participants from 1 site. The trial was first posted on 4/13/2021 and last updated on 11/8/2022."
Have there been similar tests like this one in the past?
"As of now, 497 studies regarding Durvalumab are ongoing in 65 different countries and 1844 cities. The first clinical trial for this medication was back in 2005 and involved 98 patients. It completed Phase 1 drug approval. In the 15 years since then, 395 more studies have been undertaken."
What are the primary indications for Durvalumab?
"Durvalumab is an effective pharmacotherapy for treating primary peritoneal cancer, as well as disease and other cancers."
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