Long-term Study to Evaluate and Clinical Outcomes in Patients With Favorable Intermediate Risk Localized Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Sep 26, 2027
  • participants needed
    6000
  • sponsor
    Myriad Genetic Laboratories, Inc.
Send
Updated on 26 December 2020
See if I qualify
Investigator
Bryan Dechairo, PhD
Primary Contact
Pacific Urology (8.8 mi away) Contact
+39 other location
adenocarcinoma
adenocarcinoma of prostate

Summary

This is a long-term prospective registry study to determine whether Prolaris testing in patients with favorable intermediate risk prostate cancer influences physician management decisions toward conservative treatment in patients with Prolaris low-risk scores without negatively impacting patient oncologic outcomes, thereby sparing low-risk patients from unnecessary treatments and associated side-effects.

Description

This is a long-term prospective registry to evaluate the impact of Prolaris testing on therapeutic decisions in patients with newly diagnosed favorable intermediate-risk localized prostate cancer and to summarize clinical oncologic outcomes. The design of the study is non-interventional, and therefore the protocol will not require a specific treatment plan for study participants. However, in the absence of a universally accepted timeframe for repeat biopsies within existing active surveillance recommendations, study sites will be encouraged to monitor patients for disease progression as per the standard of care (e.g., current National Comprehensive Cancer Network [NCCN] guidelines) with the expectation of a repeat biopsy within 18 months of the initial biopsy.

Patients who undergo Prolaris testing will be included in the registry as well as patients who do not undergo Prolaris testing. Data collection for the first primary objective extends over a 3-year period. During this time, data is collected on the treatment initiated, any follow-up prostate biopsy performed in patients initially treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Data collection for the second primary objective extends out to 8 years. During this time data is collected on any follow-up prostate biopsy in patients still treated with active surveillance, definitive treatments performed (with pathology data if surgical therapy is performed), and the reasons definitive treatment was pursued, as well as data related to disease progression such as biochemical recurrence, development of prostate cancer metastases, or disease specific death.

Details
Treatment Prolaris Testing
Clinical Study IdentifierNCT03290508
SponsorMyriad Genetic Laboratories, Inc.
Last Modified on26 December 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 65 yrs?
Are you male?
Do you have Malignant neoplasm of prostate?
Do you have any of these conditions: Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate or Prostate Cancer or Prostate Disorders or Prostatic disorder or prostate carcino...?
Do you have any of these conditions: Prostate Cancer, Early, Recurrent or Prostate Cancer or Malignant neoplasm of prostate or Prostate Disorders or prostate cancers or prostate carcinoma...?
Patients who have undergone CCP testing and patients who have not undergone CCP testing will be considered for enrollment in the study
Willing to provide written informed consent
Males 65 years old
Newly diagnosed (6 months), treatment-nave patient with histologically proven localized adenocarcinoma of prostate whose initial treatment has not been decided
Candidate for and considering AS and yet would be eligible for definitive therapy
Favorable intermediate-risk disease, defined by the NCCN as follows
predominant Gleason grade 3; AND
percentage of positive cores <50%; AND
no more than 1 of the following NCCN intermediate-risk factors
Gleason grade 7
T2b-T2c
PSA 10-20 ng/mL 6. Estimated life expectancy 10 years. 7. Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines)

Exclusion Criteria

\. Clinical evidence of metastasis or lymph node involvement
\. Received pelvic radiation prior to biopsy
\. Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitors (5-ARIs) are permitted
\. Participation in interventional clinical trials
\. Patient is considering watchful waiting
\. Has a known history of hypogonadism
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name
Edit Delete

Annotated by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet