High-Dose Stereotactic Radiation for Prostate Cancer

High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664130

Enrollment

Registered

2012-08-14

Start date

2012-07-31

Completion date

2017-01-12

Last updated

2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage I Prostate Cancer

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.

Interventions

RADIATIONstereotactic body radiation therapy

Undergo SBRT

PROCEDUREquality-of-life assessment

Ancillary studies

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	1.5 months	Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	4 months	Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Secondary

Measure	Time frame	Description
Quality of Life as Assessed by EPIC Scores	Baseline and 1.5 months	Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.
Quality of Life as Assessed by Change in AUA Scores	Baseline and 1.5 months	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	Baseline and 1.5 months	Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from regional hospitals from July 2012 thru Jan 2015.

Participants by arm

Arm	Count
Treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	35
Total	35

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	competing secondary disease	2

Baseline characteristics

Characteristic	Treatment (SBRT)
Age, Customized 50-59 yrs	6 Participants
Age, Customized 60-69 yrs	12 Participants
Age, Customized 70-79 yrs	15 Participants
Age, Customized 80-89 yrs	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	10 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	25 Participants
Region of Enrollment United States	35 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	35 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 35
other Total, other adverse events	34 / 35
serious Total, serious adverse events	1 / 35

Outcome results

Primary

Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Time frame: 4 months

Population: Per protocol

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment (SBRT)	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	0 Participants

Primary

Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Time frame: 8 months

Population: Per protocol

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment (SBRT)	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	0 Participants

Primary

Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Time frame: 12 months

Population: All patients that received treatment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment (SBRT)	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	0 Participants

Primary

Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Time frame: 1.5 months

Population: All patients that received treatment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Treatment (SBRT)	Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	1 Participants

Secondary

Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA

Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Time frame: Baseline and 12 months

Population: participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Arm	Measure	Value (NUMBER)
Treatment (SBRT)	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	96.5 percentage of participants

Secondary

Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA

Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Time frame: Baseline and 1.5 months

Population: participants who had a PSA values up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Arm	Measure	Value (NUMBER)
Treatment (SBRT)	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	100 percentage of participants

Secondary

Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA

Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Time frame: Baseline and 4 months

Population: participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Arm	Measure	Value (NUMBER)
Treatment (SBRT)	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	100 percentage of participants

Secondary

Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA

Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Time frame: Baseline and 8 months

Population: participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Arm	Measure	Value (NUMBER)
Treatment (SBRT)	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	96.5 percentage of participants

Secondary

Quality of Life as Assessed by Change in AUA Scores

Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.

Time frame: Baseline and 1.5 months