Clinical trial NCT01664130: High-Dose Stereotactic Radiation for Prostate Cancer
Official title: High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-14
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue

Detailed description: PRIMARY OBJECTIVES:

I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer.

SECONDARY OBJECTIVES:

I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC) and American Urological Association (AUA) scores.

II. Assess biochemical control after high-dose SBRT.

OUTLINE:

Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months, every 6 months for 4 years, and then annually thereafter.

Eligibility criteria: Inclusion Criteria:

* The patient must have prostate adenocarcinoma proven by histologic diagnosis
* The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation
* Performance status - Karnofsky performance status (PS) \>= 70
* Life expectancy of \> 5 years, in the opinion of and as documented by the investigator
* Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR \< 2.0).
* Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to enrollment
* Men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment
* Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior treatment toxicities must be resolved to =\< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
* Patients who are receiving any other investigational agents
* Evidence of metastatic disease prior to radiation
* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Prior pelvic radiation therapy
* Patients whom are planned to receive pelvic nodal radiation are excluded
* Weight \> 350 lbs
* Contraindications to placement of fiducials required for high-precision image guidance (e.g. bleeding disorders which may cause excessive bleeding with placement, requirement for coumadin, international normalized ratio \[INR\] \> 2.0)
* Patients unable to maintain a full bladder during treatment
* Previous prostatectomy
* Inflammatory bowel disease
* AUA score \> 15 in spite of optimal therapy

Primary outcomes:
measure: Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
timeFrame: 1.5 months
measure: Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
timeFrame: 4 months
measure: Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
timeFrame: 8 months
measure: Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life as Assessed by EPIC Scores
timeFrame: Baseline and 1.5 months
measure: Quality of Life as Assessed by EPIC Scores
timeFrame: Baseline and 4 months
measure: Quality of Life as Assessed by EPIC Scores
timeFrame: Baseline and 8 months
measure: Quality of Life as Assessed by EPIC Scores
timeFrame: Baseline and 12 months
measure: Quality of Life as Assessed by Change in AUA Scores
timeFrame: Baseline and 1.5 months
measure: Quality of Life as Assessed by Change in AUA Scores
timeFrame: Baseline and 4 months
measure: Quality of Life as Assessed by Change in AUA Scores
timeFrame: Baseline and 8 months
measure: Quality of Life as Assessed by Change in AUA Scores
timeFrame: Baseline and 12 months
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
timeFrame: Baseline and 1.5 months
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
timeFrame: Baseline and 4 months
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
timeFrame: Baseline and 8 months
measure: Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Kevin Stephans
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parsai S, Juloori A, Sedor G, Reddy CA, Thousand R, Magnelli A, Berglund RK, Stovsky M, Klein EA, Tendulkar RD, Stephans KL. Heterogenous Dose-escalated Prostate Stereotactic Body Radiation Therapy for All Risk Prostate Cancer: Quality of Life and Clinical Outcomes of an Institutional Pilot Study. Am J Clin Oncol. 2020 Jul;43(7):469-476. doi: 10.1097/COC.0000000000000693.