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Circulating Tumor Cells in Prostate Cancer Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01414712
First received: May 18, 2011
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Prostate Cancer
 Other: Blood Drawing

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • To review the level of changes in circulating tumor cells with radiation. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 2
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01414712     History of Changes
Other Study ID Numbers: STU 032011-212
Study First Received: May 18, 2011
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 22, 2013