Clinical trial NCT00899912: Changes in DNA After Radiation Therapy in Patients With Prostate Cancer
Official title: Investigating Markers of Radiation Outcome in Patients With Intermediate-Risk Prostate Cancer Using DNA Microarray Analysis: An RTOG Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intermediate risk prostate cancer patients

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of frozen and paraffin-embedded specimens that yield adequate RNA for tumor tissue microarray analysis
timeFrame: Specimens collected at the time of brachytherapy
Secondary outcomes:
measure: Comparison of gene expression patterns between frozen and paraffin-embedded tissue in patients treated on the brachytherapy alone arm of protocol RTOG-0232
timeFrame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
measure: 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
timeFrame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
measure: 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
timeFrame: After microarray analysis of tissue and primary endpoint analysis of RTOG 0232
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Cancer Center for Excellence at Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Springfield
country: United States
facility: Cancer Institute at St. John's Hospital
state: Illinois
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish West County Hospital
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
state: Missouri
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
state: Ohio
city: Mansfield
country: United States
facility: MedCentral - Mansfield Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Ohio State University
name: Arnab Chakravarti, MD
role: STUDY_CHAIR
References: