Prostate CancerNCT01414712
Circulating Tumor Cells in Prostate Cancer Patients
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Blood Drawing
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Low- and Intermediate-Risk Prostate Cancer wo undergo stereotactic body radiation therapy
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Circulating Tumor Cells in Patients Undergoing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
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.
Read the 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.
- Prior to CT-simulation, but more than 2 days after digital rectal examination
- Within 24 hours following CT simulation (an endorectal balloon is used at the time of simulation)
- Within 24 hours following the first treatment
- Within 24 hours following the third treatment
- Within 1 week following the fifth treatment
- Conditions
- Prostate Cancer
- Being tested
- Blood Drawing
- Keywords
- Low- and Intermediate-Risk Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawingOther
Also called Blood Drawing for prostate cancer patients who undergo stereotactic body radiotherapy
Blood Drawing to measure circulating tumor cells counts.
| Study group | Role | What they receive |
|---|---|---|
| prostate cancer patients | Not described Receives: Other: Blood Drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414712
- Sponsor's protocol ID
- STU 032011-212
- Status last verified
- Mar 2013
- First submitted
- 18 May 2011
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells in Patients Undergoing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01414712
- Acronym / sponsor ID
- STU 032011-212
- Conditions
- Prostate Cancer
- Keywords
- Low- and Intermediate-Risk Prostate Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- Prior to CT-simulation, but more than 2 days after digital rectal examination
- Within 24 hours following CT simulation (an endorectal balloon is used at the time of simulation)
- Within 24 hours following the first treatment
- Within 24 hours following the third treatment
- Within 1 week following the fifth treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prostate cancer patients | – | Other: Blood Drawing |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low- and Intermediate-Risk Prostate Cancer wo undergo stereotactic body radiation therapy
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawingAlso: Blood Drawing for prostate cancer patients who undergo stereotactic body radiotherapyBlood Drawing to measure circulating tumor cells counts. | Other | prostate cancer patients |
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To review the level of changes in circulating tumor cells with radiation. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.