CClinicalTrials.gg
Sign In
WithdrawnNCT01899391Updated Jul 15, 2013

Periperal Blood Lymphocytes During Prostate RT

An observational study in Prostate Cancer, sponsored by University Health Network, Toronto. Withdrawn. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-15.

Sponsored by University Health Network, Toronto · Observational

Why this study was withdrawn
Recuritment Challenges
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
Male
01

Study summary

Right now it is not possible to predict which patients are going to react more to RT. Many things could affect patient's response to radiation. One of the factors is whether the person can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be used to predict the sensitivity of individual patients. The investigators will be studying this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both computed tomography (CT) scan and RT treatment. This will help us to understand why different individuals show differences in side effects following RT.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • Prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

Browse Prostatic Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) 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
Yes
Sampling method
Probability sample

Study population

Patients with intermediate-risk prostate cancer

Inclusion criteria

  • Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS \< 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
  • Planned for radical RT to the prostate with IMRT planning (79Gy/39fractions or 60 Gy/20 fractions).
  • No contraindications to diagnostic CT scanning.
  • Prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes.
  • No known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT.

Exclusion criteria

Exclusion Criteria:

  • Inability to provide informed consent.
  • Patient having contraindications to diagnostic CT scan.
  • Patients who have unobtainable data regarding previous therapy and their clinical outcome.
  • Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Gamma H2AX in peripheral blood lymphocytes.

    Time frame: 1 year

Secondary outcomes

  1. Gamma H2AX following RT planning (CT scan).

    Time frame: 1 year

  2. Gamma H2AX during RT

    Time frame: 1 year

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 Jul 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01899391
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Jul 15, 2013
Start date
Aug 2009
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jul 15, 2013

Study contacts

Robert Bristow, MD
principal investigator · University Health Network, Princess Margaret Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2013. 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.

Other studies in this condition

Prostatic Neoplasms→

Other studies from this sponsor

University Health Network, Toronto

Start the discussion