NCT00991315

Brief Summary

The primary objective of this study is to collect material for study's to assess mechanisms of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers in tissue, serum and peripheral blood mononuclear cells.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

8.3 years

First QC Date

October 7, 2009

Last Update Submit

April 7, 2021

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Collection and freezing of tumor samples

    5 years

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient undergoing a routine prostatectomy or TURP (transurethral resection of the prostate) may be asked to participate

DISEASE CHARACTERISTICS: * Undergoing routine prostatectomy or transurethral resection of the prostate (TURP) PATIENT CHARACTERISTICS: 5.1.1 Patient is undergoing routine prostatectomy or TURP. 5.1.2 Patient is ≥ 18 years old. 5.1.3 Patient must give informed consent. PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected at time of TURP and will be deidentified and processed by standard procedures.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Isaac Kim, MD, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

December 12, 2008

Primary Completion

April 10, 2017

Study Completion

April 10, 2017

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

US(1)