Olaparib for Prostate Cancer

1
Effectiveness
2
Safety
Memorial Sloan Kettering Basking Ridge, Basking Ridge, NJ
Prostate Cancer+1 More
Olaparib - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a combination of two drugs may help treat prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Olaparib will improve 1 primary outcome in patients with Prostate Cancer. Measurement will happen over the course of 1 year.

1 year
Therapeutic efficacy as defined by number of participants with an undetectable PSA

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Castration Sensitive Biochemically Recurrent Prostate Cancer

This trial requires 5 total participants across 2 different treatment groups

This trial involves 2 different treatments. Olaparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Castration Sensitive Biochemically Recurrent Prostate CancerCastration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Basking Ridge - Basking Ridge, NJ

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Molecular evidence of DDR deleterious mutations (somatic or germline), including BRCA1, BRCA2, ATM, CHEK2, FANCA, RAD51C, RAD51D, PALB2, BRIP1, BARD1, or CDK12. Mutations may be truncating, splice site mutations, missense or homozygous deletions. Mutation status is determined by a local laboratory with the result documented in the subject's medical record, previously obtained genomic testing from a CLIA-certified lab, or via archival or fresh tissue.
Body weight > 30kg
Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Males 18 years of age and above
History of radical prostatectomy
Rising PSA (50% or more increase to a level of 0.50 ng/mL or more, based on at least 3 PSA determinations obtained at least 1 week apart). The 50% rise in PSA is across the 3 determinations, and these determinations do not need to be sequential.
PSA doubling time of </= 9 months as calculated according to the Memorial Sloan Kettering Cancer Center nomogram
No evidence of metastatic disease on conventional imaging (CT/MRI and bone scan). However, subjects with pelvic and/or retroperitoneal nodes < 2cm in the short axis will be permitted on study, as they are considered not to have definitive metastases. (Note: Metastatic disease on investigational imaging, Prostate Specific Membrane Antigen-targeted (PSMA) PET, PET-choline, or other novel PET tracers who do not have evidence of metastatic disease using conventional imaging (CT/MRI, bone scan) are allowed.)
ECOG status of ≤1

Patient Q&A Section

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

Can prostate cancer be cured?

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The prognosis is poor in patients with pT3a/b disease only. However, these patients have a much better long-term survival compared to patients with T3 disease, irrespective of pathological stage. Patients with advanced disease do better than previously assumed.

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How does olaparib work?

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The antiproliferative activity of olaparib was demonstrated in prostate cancer cell lines. Recent findings were not caused by inhibition of the MEK/ERK1/2 signaling pathway in vitro.

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What causes prostate cancer?

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If not diagnosed very early [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) progresses slowly; if diagnosed early, the average patient survives five years. If diagnosed a year or two after diagnosis, the average survival is just one year. And if diagnosed a few months or a few years after diagnosis the average survival is five or six months. Current guidelines (US/UK) state that prostate-specific antigen screening with prostate-specific antigen testing to detect clinically localised prostate cancer or prostate cancer with clinical or surgical stage T1c cancer (no biochemical recurrence for N.B. these early staged conditions will usually have favorable prognosis) should begin at age 70 (60, 63); when this age is approached (age 75, 70) use a one time screening PSA test.

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What are common treatments for prostate cancer?

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Treatment for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) depends on the type of cancer and how advanced it is. Common options include surgery, chemotherapy, radiation therapy, hormonal therapy, targeted therapy, or a combination of these.

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How many people get prostate cancer a year in the United States?

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Recent findings shows the total number of cases in the U.S. was around 250,000 new cases a year and more than half of these cases are African American. It also shows a decline in incidence from 1979 to 1999 and a fall in stage at diagnosis, most likely a reflection of prostate specific antigen screening over the years.

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What is prostate cancer?

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The National Comprehensive Cancer Network has developed a comprehensive and useful website with downloadable downloadable clinical tools for diagnosis, surveillance and treatment. It can be used to define and manage patients with early stage [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). By using this information, patients and health care providers can make informed decisions about early prostate cancer detection and treatment. It can also be used to help patients plan for treatment that could improve outcomes and quality of life.

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What are the signs of prostate cancer?

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It is difficult to differentiate signs and symptoms of PCa from those of BPH. However, the risk factors for PCa are also risk factors for BPH. The signs and symptoms of PCa can be separated into three main groups: signs present in the symptomatic presentation of the disease, signs indicative of the condition and signs indicative of the progression of BPH to PCa. The presence of one or more of these three signs is highly suggestive of PCa.

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What is olaparib?

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This is the first study to report OLA treatment in a large, prospective, Phase III study (Olaparib in Prostate and Ovarian Cancer (Olaparib in POC) study) of patients with metastatic and/or [recurrent prostate cancer](https://www.withpower.com/clinical-trials/recurrent-prostate-cancer). Results so far have demonstrated a significant improvement in progression-free survival and overall survival. The median duration of response was 20.4 weeks and the median progression-free survival was 13.3 weeks. The 1-year and 2-year survival rates are 96.3% and 82.9% with progression-free survival being 50.0% and 35.6% with overall survival being 66.0% and 51.9%.

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How serious can prostate cancer be?

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For most patients the [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is localized at the time of diagnosis. Prostatic cancer can be fatal in approximately 2.5% of patients who suffer from late metastatic disease. In one third of patients with metastatic disease, prostate cancer does not progress after first-line treatment. For most men with metastatic disease, prostate cancer is lethal, however, one year after androgen deprivation therapy, if no chemotherapy is given, the cause of death is almost always due to other causes; and prostate cancer-related death usually occurs 2 to 3 years after the onset of metastatic disease. Thus, prostate cancer is usually not life-threatening.

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What is the latest research for prostate cancer?

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In the last 5 years a lot of new data, not only in the treatment but also in the molecular biology of prostate cancer were published. Despite this progress our knowledge still very much depends on the availability of a cure for prostate cancer. At the end of this review is a list of important publications relevant to this subject.

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What does olaparib usually treat?

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The treatment-related toxicities of olaparib are as high as in phase II trials, but the common treatment-related adverse events in patients of the LEE011 study were different. Patients with advanced NSCLC should not take olaparib concomitantly with cytotoxic compounds such as docetaxel unless recommended by a physician.

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Who should consider clinical trials for prostate cancer?

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Overall, the most commonly cited reasons that patients cited, in order of frequency, for not participating in clinical trials were that they feared the trial would lead to more invasive testing and would not work for them. Future research and development efforts should focus on developing less invasive clinical trials for prostate cancer.

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