Trial Outcomes & Findings for Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203) (NCT NCT01856855)

Last Updated: 2023-01-12

Results Overview

Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Within 3 months of the completion of radiation therapy

Results posted on

2023-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiation Therapy With Integrated Boost Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 Participants Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	26 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	12 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 months of the completion of radiation therapy

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 Participants Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer	22 number of participants

SECONDARY outcome

Timeframe: Within 6 months of completion of radiation therapy

Feasibility will be defined as the ability of the treatment planner to create a plan that meets the following criteria: * 100% of radiation target prescription (36.25 Gy) covers greater than or equal to 95% of the target (prostate) * At least 95% of the boost prostate (area within the prostate most likely harboring cancer) prescription (38.0 Gy) covers 95% of this boost target volume * All normal tissue dose constraints are met -i.e., nearby rectum, bladder, and femoral heads do not exceed the recommended radiation dose limits If the physician must utilize a plan that compromises target coverage or normal tissue dose constraints to levels not meeting the criteria above, then the plan will be scored as not meeting technical feasibility requirements.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 Participants Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Treatment Planning Feasibility	26 Participants

SECONDARY outcome

Timeframe: Within 6 months of completion of radiation therapy

Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer at each interval follow-up visit (every three months for year one, then every 6 months for year two after treatment). "Absence of prostate cancer" is defined as no evidence of tumor recurrence by two methods: 1. No prostate cancer recurrence evident on the physical examination performed by the physician. 2. No rise in the PSA more than 2 ng/ml above the lowest PSA value ever obtained pre or post treatment. A rise in the PSA more than 2 ng/ml from a patient's lowest value is the standard definition for post-radiation PSA biochemical prostate cancer failure.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 Participants Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Early Efficacy	26 Participants

SECONDARY outcome

Timeframe: Within 6 months of completion of radiation therapy

Late toxicity (defined as toxicity occuring \>90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 Participants Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Number of Patients Who Experienced Late Toxicity	22 number of participants

SECONDARY outcome

Timeframe: Within 6 months of completion of radiation therapy

Median of quality of life score will be assessed with regular clinical exams and patient quality of life questionnaires (American Urologic Association Symptom Index score ranges from 0 to 35 with the higher scores indicating more severe, Sexual Health Inventory score ranges from 1 to 25 with 1 being severe and 25 being no signs, Extended Prostate Cancer Index Composite- Bowel, Extended Prostate Cancer Index Composite- Urinary, and Extended Prostate Cancer Index Composite- Sexual scales range from 1 (worst) to 100 (best)).

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 Participants Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Median Quality of Life Score American Urologic Association Symptom Index	11 score on a scale Interval 0.0 to 35.0
Median Quality of Life Score Sexual Health Inventory for Men	17 score on a scale Interval 1.0 to 25.0
Median Quality of Life Score Extended Prostate Cancer Index Composite-Urinary	85.8 score on a scale Interval 1.0 to 100.0
Median Quality of Life Score Extended Prostate Cancer Index Composite-Sexual	57.7 score on a scale Interval 1.0 to 100.0
Median Quality of Life Score Extended Prostate Cancer Index Composite-Bowel	91.1 score on a scale Interval 1.0 to 100.0

Adverse Events

Stereotactic Body Radiation Therapy With Integrated Boost

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stereotactic Body Radiation Therapy With Integrated Boost n=26 participants at risk Stereotactic Body Radiation Therapy with Integrated Boost: SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
Gastrointestinal disorders Diarrhea	15.4% 4/26 • Number of events 4 • 2 years
Gastrointestinal disorders Hematochezia	11.5% 3/26 • Number of events 3 • 2 years
Renal and urinary disorders Dysuria	26.9% 7/26 • Number of events 7 • 2 years
Renal and urinary disorders Urinary Retention	7.7% 2/26 • Number of events 2 • 2 years
Renal and urinary disorders Urinary Urgency	7.7% 2/26 • Number of events 2 • 2 years
Renal and urinary disorders Hematuria	3.8% 1/26 • Number of events 1 • 2 years
Renal and urinary disorders Urinary Frequency	38.5% 10/26 • Number of events 10 • 2 years

Additional Information

John Fiveash, MD

University of Alabama at Birmingham (UAB)

Phone: (205) 975-0224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place