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Combination Therapy for Prostate Cancer (ASCLEPIuS Trial)
ASCLEPIuS Trial Summary
This trial will test how well a new cancer treatment works when combined with other existing treatments. Researchers will also look at how long patients treated with this new combination live without the cancer coming back.
ASCLEPIuS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowASCLEPIuS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ASCLEPIuS Trial Design
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Who is running the clinical trial?
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- My doctor has noted a significant enlargement of my prostate's median lobe.I do not have severe heart or blood vessel problems.My organs and bone marrow are working well.My diabetes is not under control or my HbA1c level is above 10.I have active hepatitis or chronic liver disease.My prostate cancer was confirmed through a biopsy.I am allergic to niraparib, abiraterone acetate, leuprolide, or prednisone.My cancer is classified as grade group 5.I will use effective birth control during and for 3 months after treatment. I won't donate sperm during this time.I am not taking medications like phenytoin or rifampin.I have a disorder affecting my pituitary or adrenal glands.To make the criterion more understandable, we need to know what specific criteria are being referred to. Please provide the specific criteria so that I can rewrite them for you.My MRI shows a high chance of T3 cancer and it is grade 2 or higher.I have or had Crohn's disease or ulcerative colitis.My high blood pressure is not controlled, even with medication.I have a history of myelodysplastic syndrome or leukemia.I have not had major surgery in the last month.My cancer is classified as Grade Group 4.I have had treatment for prostate cancer before.I have severe depression.My tests show a high chance of advanced cancer.I haven't taken spironolactone or any experimental drugs in the last 30 days.My cancer tissue is available for DNA repair deficiency testing.My scans show cancer has spread to distant parts of my body.My prostate cancer is aggressive with a high PSA level and most biopsy samples are positive.I am 18 years old or older.My prostate is larger than 80 cc as measured by imaging.I am healthy enough for treatment and agree to follow-up appointments.I am fully active and can carry on all my pre-disease activities without restriction.My prostate cancer is aggressive, and my PSA level is 20 ng/mL or higher.I haven't taken certain cancer or hormone treatments in the last 3 months.I have a digestive condition that affects how my body absorbs food.I have had radiation therapy in the pelvic area before.I haven't had any cancer except skin or superficial bladder cancer in the last 3 years.I do not have any infections or conditions that prevent me from taking prednisone.
- Group 1: Niraparid Dose Escalation
- 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
For what purpose is Niraparib typically prescribed?
"Niraparib is an effective medication for treating patients with advanced prostate cancer, who have undergone castration, and are experiencing anemia."
Can new patients still enroll in this trial?
"The online database clinicaltrials.gov has this trial listed as currently recruiting patients. The listing was made on November 6th, 2020 and the most recent update occurred on October 18th, 2022."
Is this clinical trial being conducted in numerous hospitals across America?
"Currently, there are 4 main sites enrolling patients with additional locations. The primary enrolment centres are in Dallas, Ann Arbor and Cleveland. For anyone interested in participating it is best to choose a location close to them to limit travel."
Could you please provide more information about Niraparib and its use in medical trials?
"Niraparib was first researched in 2004 at SUNY Downstate Medical Center. So far, there have been 254 completed trials with 242 more live clinical trials currently underway. A large contingent of these studies are based out of Dallas, Texas."
How does this experiment hope to improve patient care?
"The primary outcome of this trial is biochemical failure, which will be assessed over a 112-day period. Secondary outcomes include the proportion of patients with undetectable post-treatment PSA (defined as a PSA ≤0.1 ng/mL), prostate cancer specific survival (defined as the duration of time from the start of treatment to death attributable to prostate cancer), and change in health related quality of life (assessed via EPIC-26 questionnaire)."
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