Circulating Tumor Cells in Prostate Cancer Patients

Stopped early

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01414712

Run by

University of Texas Southwestern Medical Center

People needed

2

Starts

2011-07-01

Expected to finish

2011-12-01

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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