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Hormone Therapy
Combination Therapy for Prostate Cancer (ASCLEPIuS Trial)
Phase 1 & 2
Recruiting
Led By William Jackson, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologic biopsy proven adenocarcinoma of the prostate
Grade group 5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days)
Awards & highlights
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.
Who is the study for?
Men over 18 with advanced prostate cancer, who haven't had prior treatments like radiation or anti-androgen therapy. They must have a specific grade of cancer severity, adequate organ function, and agree to use effective contraception. Exclusions include those with other recent cancers, certain heart conditions, uncontrolled diabetes or hypertension, large prostate size (>80 cc), and allergies to the trial drugs.Check my eligibility
What is being tested?
The study is testing the highest dose of niraparib (a PARP inhibitor) that's safe when combined with SBRT (targeted radiotherapy), abiraterone (hormone therapy), leuprolide (hormone therapy), and prednisone in men with prostate cancer. It also aims to see how well this combination prevents cancer from returning within three years.See study design
What are the potential side effects?
Possible side effects include hormonal changes due to abiraterone and leuprolide leading to hot flashes or sexual dysfunction; digestive issues from niraparib; fatigue; skin reactions from radiotherapy; blood pressure changes due to prednisone; plus risks of infection.
ASCLEPIuS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was confirmed through a biopsy.
Select...
My cancer is classified as grade group 5.
Select...
I will use effective birth control during and for 3 months after treatment. I won't donate sperm during this time.
Select...
My MRI shows a high chance of T3 cancer and it is grade 2 or higher.
Select...
My cancer is classified as Grade Group 4.
Select...
My prostate cancer is aggressive with a high PSA level and most biopsy samples are positive.
Select...
I am 18 years old or older.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My prostate cancer is aggressive, and my PSA level is 20 ng/mL or higher.
ASCLEPIuS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during the end of the 6th cycle of therapy (during week 24 +/- 7 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicities (Phase 1)
Proportion of patients experiencing biochemical failure
Secondary outcome measures
Change in health related quality of life
Overall survival
Proportion of patients with distant metastases
+2 moreASCLEPIuS Trial Design
1Treatment groups
Experimental Treatment
Group I: Niraparid Dose EscalationExperimental Treatment4 Interventions
Dose Level 1: 100 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT
Dose Level 2: 200 mg PO daily of Niraparib but held for 5 days (+/- 2 days) prior to RT, during SBRT, and 5 days (+/- 2 days) after last fraction of SBRT
Dose Level 3: 200 mg PO daily of Niraparib without breaks during SBRT until completion of 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~1540
Leuprolide
2008
Completed Phase 4
~18970
Stereotactic body radiotherapy (SBRT)
2015
Completed Phase 1
~50
Abiraterone Acetate
2015
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
23,997 Total Patients Enrolled
28 Trials studying Prostate Cancer
2,886 Patients Enrolled for Prostate Cancer
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,418 Total Patients Enrolled
10 Trials studying Prostate Cancer
1,243 Patients Enrolled for Prostate Cancer
Daniel Spratt, M.D.Study ChairCase Western Reserve University - Seidman Comprehensive Cancer Center
3 Previous Clinical Trials
921 Total Patients Enrolled
2 Trials studying Prostate Cancer
917 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparid Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
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