Circulating Tumor Cells in Prostate Cancer Patients

NCT01414712 | Terminated DMC

• 1 other identifier: STU 032011-212
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Low- and Intermediate-Risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To review the level of changes in circulating tumor cells with radiation.

  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.

  2 weeks

Study Arms (1)

prostate cancer patients

Other: Blood Drawing

Interventions

Blood Drawing OTHER

Blood Drawing to measure circulating tumor cells counts.

Also known as: Blood Drawing for prostate cancer patients who undergo stereotactic body radiotherapy

prostate cancer patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Low- and Intermediate-Risk Prostate Cancer wo undergo stereotactic body radiation therapy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: August 11, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 20, 2020

Record last verified: 2013-03

Locations

US (1)