CClinicalTrials.gg
CompletedNCT00535834Updated Mar 16, 2012

Studying Stored Samples From Patients With Localized Prostate Cancer Treated on Clinical Trial NCI-00-C-0154

An observational study in Prostate Cancer, sponsored by National Institutes of Health Clinical Center (CC). Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Study type
Observational
Enrollment
48
Ages
18 Years and older
Sex
Male
01

Study summary

RATIONALE: Studying samples of blood in the laboratory from patients before and after treatment may help doctors learn more about the effects of the treatment on cells.

PURPOSE: This clinical trial is studying samples collected from patients with localized prostate cancer who received treatment on clinical trial NCI-00-C-0154.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy in prostate cancer patients previously enrolled on clinical trial NCI-00-C-0154.
  • Evaluate immunologic response.

Secondary

  • Clone the underlying tumor antigens discovered through SEREX.

OUTLINE: Samples previously collected on clinical trial NCI-00-C-0154 (whole blood, serum, and peripheral mononuclear blood cells) are analyzed for immunologic responses and evidence of formation of anti-tumor antibodies. Western blot is used to detect any evidence of vaccine-induced autoantibody responses. If there is an indication of response, SEREX is used to clone the underlying antigens.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 48 is below the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of localized adenocarcinoma of the prostate
  • Received treatment on clinical trial NCI-00-C-0154

PATIENT CHARACTERISTICS:

  • Consented the use of their collected blood cells for future research while enrolled on NCI-00-C-0154

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
05

Study design

Enrollment
48 participants

Interventions

  • Procedurediagnostic procedure
  • Proceduremolecular diagnostic method
  • Procedureprotein expression analysis
06

What researchers measure

Primary outcomes

  1. Immunologic response

  2. Incidence of formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy by western blot and SEREX

Secondary outcomes

  1. Cloning of any underlying tumor antigens discovered in this process

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00535834
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
First posted
Sep 26, 2007
Completion
Mar 2011
Last update
Mar 16, 2012

Study contacts

James Gulley, MD, PhD
principal investigator · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion