Status:
TERMINATED
Circulating Tumor Cells in Prostate Cancer Patients
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18-99 years
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 ...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01414712
Start Date
July 1 2011
End Date
December 1 2011
Last Update
August 20 2020
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390