Evaluation of the Hereditary Component of Localized Prostate Cancer

C
Courtney Schroeder

Primary Investigator

Enrolling By Invitation
18-100 years
Male
Phase N/A
150 participants needed
1 Location

Brief description of study

What is the purpose of this study?
Our goals of the study include (1) Evaluating whether we can identify “at-risk” patients with localized prostate cancer who have positive germline mutations not previously known, (2) Identifying which, if any, specific pre-identified “at-risk” population groups are individually at an increased risk of carrying a gene mutation associated with prostate cancer through germline testing, (3) Identifying which, if any, specific genes are associated or clustered to any or all of the various studied “at-risk” populations by germline testing, (4) Establishing a multidisciplinary Hereditary Prostate Cancer Clinic involving urology, medical genetics and oncology and.(5) Creating a biorepository to store blood for future studies.During the subject's first appointment in the Hereditary Prostate Cancer Clinic, the research team will discuss the patient's history and the research study. The subject will be consented to the study during their initial appointment.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • Participants will complete a blood draw for genetic testing.
  • Collection of blood samples from healthy, non-pregnant adults who weigh at least 110 pounds (49.9 kg). Amount drawn will not exceed 550 ml in an 8 week period and collection will not occur more frequently than 2 times per week.
  • Collection of blood samples from adults and children, with consideration to the age, weight, and health of the subjects, along with the collection procedure, the amount of blood to be collected and the frequency of collection. Amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection will not occur more frequently than 2 times per week.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate cancer
  • Age: Between 18 Years - 100 Years
  • Gender: Male

Inclusion criteria
a)    African American males with a diagnosis of localized prostate cancer
b)    Men 50 years or younger with a diagnosis of localized prostate cancer
c)    Clinically significant prostate cancer (Gleason score of ≥7) and a first degree relative (father, brother, or son) with a diagnosis of prostate cancer
d)    Clinically significant prostate cancer (Gleason score of ≥7) and a family history of;
1.    First degree relative with breast cancer diagnosed younger than age 50
2.    First or second degree relative with ovarian cancer, pancreatic cancer or metastatic prostate cancer
3.    Ashkenazi Jewish ancestry
e)    High-risk non-metastatic disease classified by the High Risk D’Amico criteria as PSA >20, Gleason score of ≥8 or stage T2c-3a
q23235

Exclusion criteria

a)    are unable to offer informed consent
b)    have been diagnosed with metastatic prostate cancer
c)    have been diagnosed with another type of cancer previously, excluding skin cancer

Updated on 01 Aug 2024. Study ID: MMGE-IUH-VFR-466, 2004109793
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