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PARP Inhibitor
Olaparib for Prostate Cancer
Phase 2
Waitlist Available
Led By Catherine H Marshall, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks
Normal organ and bone marrow function measured within 28 days prior to administration of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial of olaparib shows that it may be effective in treating metastatic castration-resistant prostate cancer, with 11 out of 49 patients responding positively to the drug. However, more research is needed to determine the optimal timing for olaparib therapy and whether it is effective in earlier disease states.
Who is the study for?
Men with high-risk, non-metastatic prostate cancer post-prostatectomy can join this trial. They should have a rapidly rising PSA level, good physical condition (ECOG 0-1), and no prior ADT or strong CYP3A inhibitors in the last 6 months. Participants need normal organ/bone marrow function and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Olaparib's effectiveness for prostate cancer at an earlier stage than previously studied. It involves men whose cancer has returned biochemically after surgery but hasn't spread elsewhere, focusing on those with specific genetic mutations linked to DNA repair.See study design
What are the potential side effects?
Olaparib may cause blood-related issues like anemia, nausea, fatigue, digestive problems, shortness of breath, headache, muscle or joint pain. Rarely it could lead to more serious conditions such as blood clots or secondary cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent scans show no signs of cancer spread.
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My organ and bone marrow functions are normal as tested within the last 28 days.
Select...
I am a man who will use two effective birth control methods during and 3 months after the study.
Select...
My genetic test shows a harmful mutation in a specific cancer-related gene.
Select...
I am fully active or can carry out light work.
Select...
My cancer is a type of prostate cancer called adenocarcinoma.
Select...
I have had a prostatectomy and can provide tissue samples for testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate (PSA) to olaparib for patients with high-risk biochemically-recurrent prostate cancer. Measured by decline in PSA to 50% of baseline level, confirmed with a second measurement at least 4 weeks apart.
Secondary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate PSA progression-free survival, defined as a time from initiation on olaparib therapy until PSA increase of 25%, confirmed with another measurement at least 4 weeks later.
To evaluate duration of undetectable PSA
+1 moreSide effects data
From 2023 Phase 3 trial • 154 Patients • NCT0218419549%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: Olaparib 300 mg BIDExperimental Treatment1 Intervention
Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,267 Previous Clinical Trials
288,606,931 Total Patients Enrolled
1 Trials studying Prostate
298 Patients Enrolled for Prostate
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,870 Total Patients Enrolled
Catherine H Marshall, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.I had major surgery more than 2 weeks ago and have recovered from it.I cannot swallow pills or have a stomach condition that affects medication absorption.My recent scans show no signs of cancer spread.I do not have active hepatitis B or C.My organ and bone marrow functions are normal as tested within the last 28 days.I am not currently using strong or moderate drugs that affect liver enzymes.I am a man who will use two effective birth control methods during and 3 months after the study.I have never been treated with a PARP inhibitor like olaparib.I am not currently taking strong or moderate CYP3A inhibitors, or I have completed the required washout period.My heart's electrical activity is irregular, or I have a family history of long QT syndrome.I have had chemotherapy through an IV before.I have a serious health condition that is not under control.My genetic test shows a harmful mutation in a specific cancer-related gene.I am fully active or can carry out light work.My cancer is a type of prostate cancer called adenocarcinoma.I have not received a whole blood transfusion in the last 4 months.I had radiation therapy over 6 months ago, if at all.I have had a prostatectomy and can provide tissue samples for testing.I have received hormone therapy for cancer within the last 6 months.I have taken medication for hormone therapy in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Olaparib 300 mg BID
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.
Could you please provide more information on Olaparib research?
"As of now, there are 198 clinical trials researching Olaparib with 27 trials in Phase 3. The majority of the studies for Olaparib are located in Houston, Texas; however, 9319 locations operate studies for Olaparib globally."
Answered by AI
Will this clinical trial be the first of its kind?
"As of now, there are 198 ongoing studies involving Olaparib in 1462 cities and 59 countries. The first trial for Olaparib was run in 2005 by AstraZeneca. That initial study had 98 patients and completed its Phase 1 drug approval stage. 63 more studies have been completed since then."
Answered by AI
Are we currently recruiting participants for this research project?
"According to the website, this clinical trial is looking for volunteers. The study was posted on March 1st, 2017 and updated on October 24th, 2022."
Answered by AI
Is Olaparib a safe medication for patients to take?
"While Phase 2 trials don't have data supporting efficacy, there is some evidence of Olaparib's safety, resulting in a score of 2."
Answered by AI
How many people are part of this experiment?
"In total, the trial needs 50 eligible patients to commence. The pharmaceutical company sponsoring the study, AstraZeneca, will run it out of various hospitals including Thomas Jefferson University in Philadelphia, Maryland and Johns Hopkins Hospital in Baltimore, Nebraska."
Answered by AI
How many research facilities are coordinating this investigation?
"Right now, there are 4 locations where this study is taking place. The sites are situated in Philadelphia, Baltimore, Omaha and other cities. To limit the amount of travelling required, patients should enroll at the location that is closest to them."
Answered by AI
For what purpose is Olaparib most often prescribed?
"Olaparib is a medication that can be taken to treat ovarian cancer, primary peritoneal cancer, and hallucinations. It is also commonly used as a treatment for advance directives."
Answered by AI
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