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Circulating Tumor Cells in Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01414712
Recruitment Status : Terminated
First Posted : August 11, 2011
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if a non-invasive cancer treatment, high-dose stereotactic body radiotherapy (SBRT), is associated with changes in circulating tumor cells counts in patients with low- and intermediate-risk prostate cancer.

Condition or disease Intervention/treatment
Prostate Cancer Other: Blood Drawing

Detailed Description:

SBRT (stereotactic body radiotherapy) may decrease or actually increase CTC levels in patients with cancer, and knowledge about the effects of different therapies, including SBRT, on CTC levels will be of general interest to the oncology community. Patients will undergo blood draws at defined times as indicated below.

  1. Prior to CT-simulation, but more than 2 days after digital rectal examination
  2. Within 24 hours following CT simulation (an endorectal balloon is used at the time of simulation)
  3. Within 24 hours following the first treatment
  4. Within 24 hours following the third treatment
  5. Within 1 week following the fifth treatment

Study Design

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Tumor Cells in Patients Undergoing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
Study Start Date : July 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
prostate cancer patients Other: Blood Drawing
Blood Drawing to measure circulating tumor cells counts.
Other Name: Blood Drawing for prostate cancer patients who undergo stereotactic body radiotherapy


Outcome Measures

Primary Outcome Measures :
  1. To review the level of changes in circulating tumor cells with radiation. [ Time Frame: 2 weeks ]
    The investigator will review the coutns of circulating tumor cells (CTC). If there are significant changes in CTC levels with radiation, future studies will determine the prognostic significance of this information.


Biospecimen Retention:   Samples Without DNA
blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Low- and Intermediate-Risk Prostate Cancer wo undergo stereotactic body radiation therapy
Criteria

Inclusion Criteria:

Men who satisfy all of the following conditions will be eligible for this study:

  • Willing and capable to provide informed consent
  • Signed study specific informed consent form.
  • PSA ≤ 20 prior to hormone therapy (if given) for patients with Gleason 2-6. For those with Gleason score of 7. PSA should be less than or equal to 15 ng/ml prior to hormonal therapy (if given). Thus, risk of pelvic lymph node involvement according to Roach formula would be under 20%.
  • Gleason score ≤ 7
  • Appropriate staging studies identifying as AJCC stage T1a, T1b, T1c, T2a, or T2b
  • No direct evidence of regional or distant metastases after appropriate staging studies
  • Histologic confirmation of cancer by biopsy
  • Adenocarcinoma of the prostate
  • Age ≥ 18
  • Zubrod Performance Status 0-2
  • Up to 9 months of previous hormonal therapy is allowed (but not required)
  • AUA score must be ≤ 15 (alpha blockers allowed)
  • CT or Ultrasound-based volume estimation of prostate gland ≤ 60 grams
  • Agreement to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.

Exclusion Criteria:

Women are not eligible for this study. Men with one or more of the following conditions also are ineligible for this study:

  • Positive lymph nodes or metastatic disease from prostate cancer
  • Prior invasive malignancy unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, or cervix, or non-melanomatous skin cancer are all permissible)
  • T2c, T3, or T4 tumors
  • Previous pelvic radiotherapy
  • Previous surgery or chemotherapy for prostate cancer
  • Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate
  • Previous hormonal therapy given for more than 9 months prior to therapy
  • Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiotherapy, and chemotherapy) while on this protocol.
  • History of Crohn's Disease or Ulcerative Colitis.
  • Previous significant obstructive symptoms; AUA score must be ≤ 15 (alpha blockers allowed)
  • Significant psychiatric illness
  • Men of reproductive potential may not participate unless they agree to use an effective contraceptive method.
  • Ultrasound or CT estimate of prostate volume > 60 grams
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414712


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jeffrey Meyer, MD University of Texas Southwestern Medical Center
More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01414712     History of Changes
Other Study ID Numbers: STU 032011-212
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by University of Texas Southwestern Medical Center:
Low- and Intermediate-Risk Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes