Trial Outcomes & Findings for MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer (NCT NCT03664193)

Last Updated: 2021-01-05

Results Overview

Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

2 months

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=30 Participants Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Age, Continuous	73 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Patients who received stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB).

Outcome measures

Outcome measures
Measure	Single Arm n=30 Participants Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). Radiation dose - 37.5Gy	9 Participants
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). Radiation Dose - 40.0Gy	14 Participants
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). Radiation Dose - 42.5Gy	2 Participants
Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). Radiation Dose - 45Gy	5 Participants

PRIMARY outcome

Timeframe: 1month

Population: Patients who receive radiation dose levels of 37.5, 40, 42.5 or 45 Gy.

Outcome measures

Outcome measures
Measure	Single Arm n=30 Participants Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.	30 Participants

SECONDARY outcome

Timeframe: baseline, 3-6 months post treatment start

Population: Each time the HRQOL was administered, anywhere from 6 to 26 participants elected not to complete all the sections of the HRQOL. As such, the number of participants analyzed differs for each time point of HRQOL assessment.

Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short-form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.

Outcome measures

Outcome measures
Measure	Single Arm n=24 Participants Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. Baseline Urinary function	87.9 score on a scale Interval 45.3 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. Baseline Bowel Function	93.1 score on a scale Interval 50.0 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. Baseline Sexual function	58.5 score on a scale Interval 16.8 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. Baseline Hormonal Function	90 score on a scale Interval 80.0 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. 3-6 months post - Urinary function	93.1 score on a scale Interval 52.8 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. 3-6 months post - Bowel Function	94.2 score on a scale Interval 54.2 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. 3-6 months post - Sexual Function	53.3 score on a scale Interval 12.5 to 100.0
Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. 3-6 months post - Hormonal Function	82.8 score on a scale Interval 80.0 to 100.0

SECONDARY outcome

Timeframe: baseline, 3-6 months post treatment start

Population: Each time the AUA assessment was administered, anywhere from 2 to 3 participants elected not to complete all sections of the AUA assessment. As such, the number of participants analyzed differs for each time point of AUA assessment.

Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up. The American Urological Association (AUA) has developed the following questionnaire to help men determine how bothersome their urinary symptoms are and to check how effective their treatment is. 0-7 is mild, 8-19 is moderate and 20-35 is severe.

Outcome measures

Outcome measures
Measure	Single Arm n=28 Participants Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
American Urological Association (AUA) Questionnaire Will be Assessed. Baseline	6 score on a scale Interval 1.0 to 14.0
American Urological Association (AUA) Questionnaire Will be Assessed. 3-6 month post RT	6 score on a scale Interval 1.0 to 13.0

Adverse Events

Single Arm

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=30 participants at risk Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	3.3% 1/30 • Number of events 1 • The adverse events were collected over a time period of 6 months. The adverse events were collected based on the CTCAEv4.03.

Other adverse events

Other adverse events
Measure	Single Arm n=30 participants at risk Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
Renal and urinary disorders Urinary Frequency	76.7% 23/30 • Number of events 23 • The adverse events were collected over a time period of 6 months. The adverse events were collected based on the CTCAEv4.03.
Renal and urinary disorders Urinary retention	6.7% 2/30 • Number of events 2 • The adverse events were collected over a time period of 6 months. The adverse events were collected based on the CTCAEv4.03.
General disorders Fatigue	13.3% 4/30 • Number of events 4 • The adverse events were collected over a time period of 6 months. The adverse events were collected based on the CTCAEv4.03.
Renal and urinary disorders Urethritis	3.3% 1/30 • Number of events 1 • The adverse events were collected over a time period of 6 months. The adverse events were collected based on the CTCAEv4.03.

Additional Information

Josephine Kang

Weill Cornell Medicine

Phone: 212-746-3607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place