Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer (NCT NCT01540994)

Last Updated: 2025-01-16

Results Overview

Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.

Results posted on

2025-01-16

Participant Flow

Between 2011 and 2018 patients with prostate cancer were enrolled from the Radiation Oncology clinic.

Participant milestones

Participant milestones
Measure	Radiation Therapy: Stereotactic Body Radiation Therapy All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

12 patients received treatment as per protocol specifications.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy: Prostate Stereotactic Body Radiation Therapy n=12 Participants All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.
Age, Categorical <=18 years	0 Participants n=5 Participants • 12 patients received treatment as per protocol specifications.
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants • 12 patients received treatment as per protocol specifications.
Age, Categorical >=65 years	7 Participants n=5 Participants • 12 patients received treatment as per protocol specifications.
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.

Population: 12 participants who were enrolled in the study

Outcome measures

Outcome measures
Measure	Radiation Therapy: Prostate Stereotactic Body Radiation Therapy n=12 Participants All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Genitourinary Toxicity Grade 1	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Genitourinary Toxicity Grade 2	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Lower Gastrointestinal Toxicity Grade 5	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Gastrointestinal Toxicity Grade 2	2 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Genitourinary Toxicity Grade 4	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Lower Gastrointestinal Toxicity Grade 2	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Lower Gastrointestinal Toxicity Grade 3	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Lower Gastrointestinal Toxicity Grade 4	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Genitourinary Toxicity: 0 (none)	8 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Genitourinary Toxicity Grade 1	4 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Genitourinary Toxicity Grade 2	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Genitourinary Toxicity Grade 3	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Genitourinary Toxicity: 0 (none)	11 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Genitourinary Toxicity Grade 3	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Genitourinary Toxicity Grade 4	1 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Genitourinary Toxicity Grade 5	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Lower Gastrointestinal Toxicity: 0 (none)	12 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Acute Lower Gastrointestinal Toxicity Grade 1	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Genitourinary Toxicity Grade 5	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Gastrointestinal Toxicity: 0 (none)	10 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Gastrointestinal Toxicity Grade 1	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Gastrointestinal Toxicity Grade 3	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Gastrointestinal Toxicity Grade 4	0 participants
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. Late Gastrointestinal Toxicity Grade 5	0 participants

SECONDARY outcome

Timeframe: mean 41 months (range 3-84 months)

Population: 12 participants who were enrolled in the study

Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have "biochemical failure" if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having "biochemical failure" will be deemed as "biochemically disease-free".

Outcome measures

Outcome measures
Measure	Radiation Therapy: Prostate Stereotactic Body Radiation Therapy n=12 Participants All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.
Rate of Biochemical Disease-free Status	10 participants

Adverse Events

Radiation Therapy: Prostate Stereotactic Body Radiation Therapy

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiation Therapy: Prostate Stereotactic Body Radiation Therapy n=12 participants at risk All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.
Gastrointestinal disorders Rectal bleeding	8.3% 1/12 • Number of events 1 • Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
Renal and urinary disorders Acute Genitourinary Toxicity (Grade 4)	8.3% 1/12 • Number of events 1 • Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.

Other adverse events

Other adverse events
Measure	Radiation Therapy: Prostate Stereotactic Body Radiation Therapy n=12 participants at risk All patients entered in the study will be referred to the Radiation Oncology department for standard consultation for a newly-diagnosed prostate cancer. During the course of the initial consultation the patients will be given various treatment options depending on their tumor characteristics. If appropriate they will also be given the option of being treated on-protocol using the stereotactic body radiosurgery approach. All patients enrolled on this protocol will receive 35Gy in 5 fractions delivered every other day using a multi-field 6MV photon IMRT technique treating the prostate with limited (2-4mm) margin, and daily rectal balloon placement to assist with prostate immobilization.
Renal and urinary disorders Late Genitourinary Toxicity (Grade 1)	33.3% 4/12 • Number of events 4 • Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
Gastrointestinal disorders Late Gastrointestinal Toxicity (Grade 2)	16.7% 2/12 • Number of events 2 • Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.

Additional Information

Dr. Geoffrey Weinstein

Sharp Healthcare

Phone: 858-939-5010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place