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PD-L1 Inhibitor

Olaparib for Prostate Cancer

Phase 2
Waitlist Available
Led By Karen Autio, MD, MsC
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of radical prostatectomy
Life expectancy of ≥ 52 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will compare olaparib and durvalumab to the standard of care for treating prostate cancer.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have had surgery to remove your entire prostate gland.
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You are expected to live for at least a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic efficacy as defined by number of participants with an undetectable PSA

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
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%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Neuropathy peripheral
10%
Pruritus
9%
Dizziness
9%
Thrombocytopenia
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
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%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Dysgeusia
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%
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%
General physical health deterioration
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: Castration Sensitive Biochemically Recurrent Prostate CancerExperimental Treatment2 Interventions
Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,803 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,899 Patients Enrolled for Prostate Cancer
Karen Autio, MD, MsCPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to sign patients up for this research project?

"From what is publicly available on clinicaltrials.gov, this study isn't recruiting patients at the moment. The listing for this trial was created on March 7th, 2019 and last updated on March 30th, 2020. There are 1865 other trials that are actively looking for participants though."

Answered by AI

What sets this research apart from other similar projects?

"Olaparib has a long clinical history, with the first trial being conducted in 2005. Since then, there have been 498 active trials in locations as varied as 1844 cities and 65 countries."

Answered by AI

How many people have signed up to participate in this experiment?

"Right now, this particular trial isn't screening for new patients. It was originally posted on March 7th, 2019 and most recently updated on March 30th, 2022. For individuals still looking to participate in research studies, there are 1367 prostate cancer trials and 498 Olaparib investigations actively admitting patients."

Answered by AI

Is this clinical trial exclusive to the United States or are other countries involved as well?

"11 hospitals are recruiting patients for this trial, some of which include Memoral Sloan Kettering Basking Ridge in Basking Ridge, Memoral Sloan Kettering Westchester in Harrison, and Memorial Sloan - Kettering Cancer Center in New york."

Answered by AI

What is the approved indication for Olaparib?

"Olaparib is often used to manage patients with cancer. Additionally, this medication can be given to those suffering from primary peritoneal cancer and those with advance directives."

Answered by AI

Are there any short-term dangers associated with Olaparib?

"Olaparib has received a score of 2 from our team at Power. This is because, although there is some evidence attesting to its safety, there are no Phase 2 trials demonstrating the efficacy of Olaparib."

Answered by AI

What are some other clinical studies that have used Olaparib?

"Olaparib's clinical trials started in 2005 at Research Site. So far, there have been a total of 165 completed studies. There are 498 active clinical trials as of now, with a large number of these based in Basking Ridge, New jersey."

Answered by AI
~1 spots leftby Mar 2025