Trial Outcomes & Findings for Stereotactic Body Radiotherapy for Prostate Cancer (NCT NCT01352598)

Last Updated: 2020-09-23

Results Overview

Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

one year

Results posted on

2020-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiotherapy Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Overall Study STARTED	84
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Body Radiotherapy for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Body Radiotherapy n=84 Participants Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	61 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	84 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	5 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	84 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiotherapy n=71 Participants Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Biochemical Control Rate Complete, partial, or stable tumor control	71 Participants
Biochemical Control Rate Disease progression	0 Participants

SECONDARY outcome

Timeframe: one year

Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiotherapy n=74 Participants Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Late Toxicity Rate Patients who experienced no adverse events	68 Participants
Late Toxicity Rate Patients who experienced adverse events	6 Participants

Adverse Events

Stereotactic Body Radiotherapy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stereotactic Body Radiotherapy n=74 participants at risk Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Renal and urinary disorders GU Bleeding	1.4% 1/74 • Number of events 1 • 5 years Adverse event and mortality information collection was limited by 12 study subjects that became unavailable or otherwise did not respond during the course of the 5 year follow-up period. 10 of these 12 study subjects did not make follow-up appointments and were not able to be contacted prior to the end of the first year of follow-up. This caused some discrepancy within the number of patients for whom adverse event data and mortality affects and applies to within the record.

Other adverse events

Other adverse events
Measure	Stereotactic Body Radiotherapy n=74 participants at risk Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Renal and urinary disorders Change in urinary frequency	5.4% 4/74 • Number of events 4 • 5 years Adverse event and mortality information collection was limited by 12 study subjects that became unavailable or otherwise did not respond during the course of the 5 year follow-up period. 10 of these 12 study subjects did not make follow-up appointments and were not able to be contacted prior to the end of the first year of follow-up. This caused some discrepancy within the number of patients for whom adverse event data and mortality affects and applies to within the record.
Reproductive system and breast disorders Impotence	1.4% 1/74 • Number of events 1 • 5 years Adverse event and mortality information collection was limited by 12 study subjects that became unavailable or otherwise did not respond during the course of the 5 year follow-up period. 10 of these 12 study subjects did not make follow-up appointments and were not able to be contacted prior to the end of the first year of follow-up. This caused some discrepancy within the number of patients for whom adverse event data and mortality affects and applies to within the record.
Renal and urinary disorders Dysuria	1.4% 1/74 • Number of events 1 • 5 years Adverse event and mortality information collection was limited by 12 study subjects that became unavailable or otherwise did not respond during the course of the 5 year follow-up period. 10 of these 12 study subjects did not make follow-up appointments and were not able to be contacted prior to the end of the first year of follow-up. This caused some discrepancy within the number of patients for whom adverse event data and mortality affects and applies to within the record.

Additional Information

Jaymeson Stroud, MD

Mercy

Phone: 314-251-6844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place