NCT02470897 · REGISTRY CONDITION SEARCH

Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2026-10-13

This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Experiencing Gastrointestinal (GI) Acute Toxicity

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outcome · POSTED

Number of Participants Experiencing Genitourinary (GU) Acute Toxicity

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outcome · POSTED

Number of Participants Experiencing GI Late Toxicity

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outcome · POSTED

Number of Participants Experiencing GU Late Toxicity

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outcome · POSTED

Disease-free Survival as Measured by the Phoenix Definition

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outcome · POSTED

Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Urinary Incontinence Sub-Domain

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outcome · POSTED

Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Urinary Irritative / Obstructive Sub-Domain

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outcome · POSTED

Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Bowel Sub-Domain

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outcome · POSTED

Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Sexual Sub-Domain

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outcome · POSTED

Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Hormonal Sub-Domain

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outcome · POSTED

Change in American Urological Association Symptom Score (AUASS)

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outcome · POSTED

Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 180 days of study enrollment * History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment * Gleason score =\< 7, no tertiary pattern \>= 5 * Clinical stage =\< T2b (American Joint Committee on Cancer (AJCC) 7th Edition Staging Manual) and no radiographic evidence of T3 or T4 disease * Clinical stage N0, M0 * Most recent prostate specific antigen (PSA) within 60 days of enrollment * Maximum PSA =\< 20 ng/ml (not within 20 days after biopsy) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * American Urological Association (AUA) =\< 18 with or without medical management * Up to a total of year of androgen deprivation allowed. * Participant signs study specific informed consent prior to study enrollment Exclusion Criteria: * For Arm A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan * For both Arm A and Arm B: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years; (for example, carcinoma in situ of the bladder or oral cavity is permissible) * Prosthetic implants in the pelvic region that the investigator feels will impede treatment, planning, or delivery (e.g., an artificial hip) * =\< 3 months from a transurethral resection of the prostate (TURP) procedure * Significant urinary obstruction (i.e. AUA symptom score \> 18) * Previous pelvic irradiation, prostate brachytherapy * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Severe, active comorbidity, defined as follows: * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Crohn's disease or ulcerative colitis * Scleroderma
healthy Volunteers: false
sex: MALE
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose
intervention Names
Radiation: Radiation Therapy Treatment Planning and Simulation
Radiation: SBRT
label
Arm A (moderate dose SBRT with SIB)
type
EXPERIMENTAL
description
Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose
intervention Names
Radiation: Radiation Therapy Treatment Planning and Simulation
Radiation: SBRT
label
Arm B (uniform dose SBRT)
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm A (moderate dose SBRT with SIB)
Arm B (uniform dose SBRT)
description
Undergo urethral-sparing IMRT planning
name
Radiation Therapy Treatment Planning and Simulation
other Names
Radiation Therapy Treatment Planning/Simulation
type
RADIATION
arm Group Labels
Arm A (moderate dose SBRT with SIB)
description
Undergo moderate dose SBRT with SIB
name
SBRT
other Names
Stereotactic Body Radiation Therapy
type
RADIATION
arm Group Labels
Arm B (uniform dose SBRT)
description
Undergo uniform dose SBRT
name
SBRT
other Names
Stereotactic Body Radiation Therapy
type
RADIATION

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 115
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost (SIB - Arm A). Acute Toxicity is defined as occurring on-treatment or within 6 weeks.
measure
Number of Participants Experiencing Gastrointestinal (GI) Acute Toxicity
time Frame
during treatment (days 1 to 5), 6 week follow up
description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for added grade 3 rectal toxicity with the use of a simultaneous integrated boost (SIB - Arm A). Acute toxicities were defined as occurring on-treatment or within 6 weeks.
measure
Number of Participants Experiencing Genitourinary (GU) Acute Toxicity
time Frame
during treatment (days 1 to 5), 6 week follow up
description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost (Arm A). A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of radiation therapy (RT).
measure
Number of Participants Experiencing GI Late Toxicity
time Frame
Every 6 months up to 6 years
description
Evaluation of delivering SBRT to the prostate using non-uniform dosing. The investigators will evaluate the potential for any added grade 3 rectal toxicity with the use of a simultaneous integrated boost (Arm A). A late adverse event will be defined as an adverse event occurring more than 90 days from the completion of RT.
measure
Number of Participants Experiencing GU Late Toxicity
time Frame
Every 6 months up to 6 years
description
Disease-free failure events include local progression, distant progression biochemical failure as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, and death from any cause. Participants will be considered to be without biochemical recurrence if either the PSA is still declining or the prostate-specific antigen (PSA) has not risen above its nadir by ≥ 2 ng/ml (Phoenix definition).
measure
Disease-free Survival as Measured by the Phoenix Definition
time Frame
Up to 5 years

secondary Outcomes

description
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Urinary Incontinence Sub-Domain
time Frame
at Baseline, 1 year, and 2 years
description
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Urinary Irritative / Obstructive Sub-Domain
time Frame
at Baseline, 1 year, and 2 years
description
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Bowel Sub-Domain
time Frame
at Baseline, 1 year, and 2 years
description
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Sexual Sub-Domain
time Frame
at Baseline, 1 year, and 2 years
description
The EPIC 26 assessment scores each of 5 domains on a scale of 1-100 where higher scores indicate higher satisfaction. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in Expanded Prostate Cancer Index Composite (EPIC) 26 Quality of Life Assessment: Hormonal Sub-Domain
time Frame
at Baseline, 1 year, and 2 years
description
The AUASS has a total possible range of scores of 0-35 where 1-7 is considered mild symptoms, 8-19 is considered moderate symptoms, and 20-35 is considered severe symptoms. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in American Urological Association Symptom Score (AUASS)
time Frame
at Baseline, 1 year, and 2 years
description
The IIEF-5 questionnaire has a total score of 1-25 where 1-7 is considered severe erectile dysfunction (ED), 8-11 is moderate ED, 12-16 is mild-moderate ED, 17-21 is mild ED, and 22-25 is no ED. Questionnaires will be performed prior to treatment, and one and two years after completion of treatment.
measure
Change in International Index of Erectile Dysfunction Questionnaire (IIEF-5)
time Frame
at Baseline, 1 year, and 2 years

Full study description

brief Summary: This phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.
detailed Description: PRIMARY OBJECTIVES: I. To evaluate the incidence of genitourinary (GU) and gastrointestinal (GI) acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with simultaneous integrative boost, urethral ring sparing, and enhanced prostate localization (magnetic resonance imaging \[MRI\\-computed tomography \[CT\] fusion). II. To also evaluate the incidence of GU and GI acute and late toxicity for patients treated with prostate stereotactic body radiotherapy (SBRT) with a more conventional and uniformly delivered dose of 7.25 Gy/fraction to the prostate. III. Disease-free survival: disease-free failure events include local progression, distant progression, biochemical failure as defined by the Radiation Therapy Oncology Group (RTOG) Phoenix definition, and death from any cause. SECONDARY OBJECTIVES: I. Evaluate patient quality of life (QOL) using the Expanded Prostate Cancer Index Composite 26 (EPIC-26) for evaluation of the QOL for up to 3 years after the completion of SBRT. OUTLINE: Participants are assigned to 1 of 2 treatment arms. Participants unable to undergo MRI, whose MRI proves technically inadequate for delineating needed anatomic structures, or who decline to enroll on Arm A are assigned to Arm B. Arm A: (n = 120) Participants undergo 5 fractions of moderate dose SBRT with simultaneous integrated boost (SIB) every other day for 10 days following urethral-sparing IMRT planning. Arm B: (n = 40) Participants undergo 5 fractions of uniform dose SBRT every other day for 10 days following undergo urethral-sparing IMRT planning. After completion of study treatment, patients are followed up at 4-8 weeks, at 4, 8, and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then every 12 months thereafter. Per protocol amendment in December 2023, the follow up time period for data collection will change to 3 years after the last participant completed treatment.

Source references

references

citation
Morris BA, Holmes EE, Anger NJ, Cooley G, Schuster JM, Hurst N, Baschnagel AM, Bassetti MF, Blitzer GC, Chappell RJ, Bayliss RA, Morris ZS, Ritter MA, Floberg JM. Toxicity and Patient-Reported Quality-of-Life Outcomes After Prostate Stereotactic Body Radiation Therapy With Focal Boost to Magnetic Resonance Imaging-Identified Prostate Cancer Lesions: Results of a Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):613-623. doi: 10.1016/j.ijrobp.2023.05.004. Epub 2023 May 12.
pmid
37179035
type
RESULT