Prostate CancerNCT00899912
Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by Radiation Therapy Oncology Group at 10 sites in United States.
Trial summary
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- microarray analysis and diagnostic laboratory biomarker analysis
- How many people
- 13 participants
- Where
- 10 sitesUnited States
- Study dates
- Jun 2006to Nov 2013
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Intermediate risk prostate cancer patients
Who may be able to join
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- Zubrod performance 0-1
- Clinical stages T1c - T2b, N0, M0
- Combined Gleason score 7 if prostate specific antigen (PSA) < 10, combined Gleason score < 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.
- American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).
- Age ≥ 18 years old and must sign a study-specific informed consent form
Who cannot join
- No clinically or pathologically involved lymph nodes
- No distant metastases or significant obstructive symptoms
- No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed.
- No previous hormonal therapy beginning < 2 months or > 6 months prior to registration is allowed.
- No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
- No hip prosthesis or major medical or psychiatric illnesses are allowed. prior to study entry.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory Crawford Long Hospital
Atlanta, Georgia, 30308
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City of Saint Peters, Missouri, 63376
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
MedCentral - Mansfield Hospital
Mansfield, Ohio, 44903
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
Cancer Institute at St. John's Hospital
Springfield, Illinois, 62702
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Barnes-Jewish West County Hospital
St Louis, Missouri, 63141
About this study
Official title: Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in patients with prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded, to yield RNA of adequate quality to perform DNA microarray studies on markers of radiotherapy outcome in patients with intermediate-risk prostate cancer.
Secondary
- Compare the gene expression results from frozen tissue and paraffin-embedded tissue to see the correlation between the 2 methods in patients treated on the brachytherapy alone arm of protocol RTOG-0232.
- Find genes that are expressed differentially before and after radiation therapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232.
- Find gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure.
OUTLINE: This is a multicenter, pilot study.
Frozen and paraffin-embedded tissue samples are studied for biomarker/laboratory analysis. DNA microarray analysis is performed on the samples to assess markers of radiotherapy outcome.
PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- microarray analysis, diagnostic laboratory biomarker analysis
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microarray analysisGenetic
diagnostic laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis
Measured: Specimens collected at the time of brachytherapy
Secondary outcomes (3)
Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232
Measured: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Comparison of genes to determine which are expressed differentially before and after radiotherapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232
Measured: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure
Measured: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJun 2006
- Primary completionNov 2013
- Study completionNov 2013
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.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arnab Chakravarti, MD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899912
- Sponsor's protocol ID
- RTOG-0612
- Other IDs
- CDR0000490025, NCI-2009-00734
- Status last verified
- Nov 2015
- First submitted
- 9 May 2009
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study
- ClinicalTrials.gov ID
- NCT00899912
- Acronym / sponsor ID
- RTOG-0612
- Conditions
- Prostate Cancer
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2006
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 May 2009 (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.
RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA after radiation therapy and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in DNA after radiation therapy in patients with prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Demonstrate the feasibility of acquiring specimens, both frozen and paraffin-embedded, to yield RNA of adequate quality to perform DNA microarray studies on markers of radiotherapy outcome in patients with intermediate-risk prostate cancer.
Secondary
- Compare the gene expression results from frozen tissue and paraffin-embedded tissue to see the correlation between the 2 methods in patients treated on the brachytherapy alone arm of protocol RTOG-0232.
- Find genes that are expressed differentially before and after radiation therapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232.
- Find gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure.
OUTLINE: This is a multicenter, pilot study.
Frozen and paraffin-embedded tissue samples are studied for biomarker/laboratory analysis. DNA microarray analysis is performed on the samples to assess markers of radiotherapy outcome.
PROJECTED ACCRUAL: A total of 156 patients will be accrued for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intermediate risk prostate cancer patients
Key inclusion criteria (6 listed)
- Histologically confirmed, locally confined adenocarcinoma of the prostate
- Zubrod performance 0-1
- Clinical stages T1c - T2b, N0, M0
- Combined Gleason score 7 if prostate specific antigen (PSA) < 10, combined Gleason score < 7 if PSA 10 - 20; PSA must be ≤ 20 ng/mL, before hormone therapy, if given, and a prostate volume by transrectal ultrasound (TRUS) ≤ 60 cc.
- American Urological Association (AUA) score ≤ 15 (alpha blockers are allowed).
Key exclusion criteria (6 listed)
- No clinically or pathologically involved lymph nodes
- No distant metastases or significant obstructive symptoms
- No prior chemotherapy, pelvic radiation, transurethral prostatectomy (TURP), cryosurgery, TUNA, transurethral microwave thermotherapy (TUMT) or radical surgery for carcinoma of the prostate is allowed.
- No previous hormonal therapy beginning < 2 months or > 6 months prior to registration is allowed.
- No previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless the patient is disease free for ≥ 5 years.
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 |
|---|---|---|
| microarray analysis | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
Primary outcome
Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis
Time frame: Specimens collected at the time of brachytherapy
3 secondary outcomes
Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232
Time frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Comparison of genes to determine which are expressed differentially before and after radiotherapy in patients treated on the brachytherapy plus external-beam radiation therapy arm of protocol RTOG-0232
Time frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Gene expression patterns in patients treated on either arm of protocol RTOG-0232 who have significant associations with biochemically as well as clinically apparent local and distant failure
Time frame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Arnab Chakravarti, MD study chair
Ohio State University
10 sites 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 Radiation Therapy Oncology Group at 10 sites 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis (time frame: Specimens collected at the time of brachytherapy). 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 17 Nov 2015.