Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer (NCT NCT00547339)
NCT ID: NCT00547339
Last Updated: 2022-12-07
Results Overview
Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
COMPLETED
PHASE1/PHASE2
94 participants
90 days after start of treatment
2022-12-07
Participant Flow
A total of 94 patients were recruited. Two patients withdrew consent before treatment and an additional patient had Gleason 9 disease upon pathology review and was excluded from the analysis. A total of 91 patients were analyzed.
Participant milestones
| Measure |
Phase 1: Dose Escalation 45 Gy Arm
Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 45 Gy).
|
Phase 1: Dose Escalation 47.5 Gy Arm
Dose escalation portion will be 9.5 Gy per fraction for 5 fractions (total dose = 47.5 Gy).
|
Phase 1: Dose Escalation 50 Gy Arm
Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 50 Gy).
|
Phase 2: Dose Escalation 50 Gy Arm
Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 50 Gy).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
47
|
|
Overall Study
COMPLETED
|
15
|
15
|
14
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Escalation 45 Gy Arm
Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 45 Gy).
|
Phase 1: Dose Escalation 47.5 Gy Arm
Dose escalation portion will be 9.5 Gy per fraction for 5 fractions (total dose = 47.5 Gy).
|
Phase 1: Dose Escalation 50 Gy Arm
Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 50 Gy).
|
Phase 2: Dose Escalation 50 Gy Arm
Dose escalation portion will be 9 Gy per fraction for 5 fractions (total dose = 50 Gy).
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase 1: SBRT- 45 Gy(SBRT) 45 Gy.
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: Stereotactic Body Radiation Therapy (SBRT) 50 Gy.
n=14 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 Participants
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
65 years
n=4 Participants
|
66 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
91 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 90 days after start of treatmentPopulation: Total enrolled was 47 patients to the phase I study, although two withdrew consent before treatment and an additional patient had Gleason 9 disease upon pathology and was excluded from the analysis. MTD not met in Phase I.
Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
n=14 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 Participants
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 18 monthsTo determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=47 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
No. of Late Severe GU Toxicity (for Phase 2 Only)
Grade III
|
3 participants
|
—
|
—
|
—
|
|
No. of Late Severe GU Toxicity (for Phase 2 Only)
Grade IV
|
1 participants
|
—
|
—
|
—
|
|
No. of Late Severe GU Toxicity (for Phase 2 Only)
Grade V
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 18 monthsTo determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=47 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
No. of Late Severe GI Toxicity (for Phase 2 Only)
Grade III
|
4 participants
|
—
|
—
|
—
|
|
No. of Late Severe GI Toxicity (for Phase 2 Only)
Grade IV
|
2 participants
|
—
|
—
|
—
|
|
No. of Late Severe GI Toxicity (for Phase 2 Only)
Grade V
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 months from start of treatmentTo determine acute severe GU toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=47 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
GU Toxicity (Only Phase 2)
Grade III
|
0 participants
|
—
|
—
|
—
|
|
GU Toxicity (Only Phase 2)
Grade IV
|
0 participants
|
—
|
—
|
—
|
|
GU Toxicity (Only Phase 2)
Grade V
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 9 months from start of treatmentTo determine acute severe GI toxicity is defined as grade 3-5 occurring prior to 270 days from the start of the protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=47 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
GI Toxicity
Grade III
|
1 participants
|
—
|
—
|
—
|
|
GI Toxicity
Grade IV
|
1 participants
|
—
|
—
|
—
|
|
GI Toxicity
Grade V
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: The data was not collected.
To determine non-GU (genitourinary) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: The data was not collected.
To determine non-GI (gastrointestinal) toxicity is defined as grade 3-5. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Phase 1: SBRT- 45Gy was the only arm to have a patient with biochemical progression.
Biochemical failure RTOG (Radiation Therapy Oncology Group)-ASTRO (American Society for Therapeutic Radiology and Oncology) definition (also known as Phoenix definition). Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
n=14 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 Participants
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
Freedom From Biochemical Failure
|
90.9 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 60 monthsThe survival time will be measured from the date of accession to the date of death.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
n=14 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 Participants
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
Overall Survival
|
71.5 percentage of participants
|
85 percentage of participants
|
92 percentage of participants
|
98 percentage of participants
|
SECONDARY outcome
Timeframe: 60 monthsDisease-Specific Survival Disease-specific survival will be measured from the date of study entry to the date of death due to prostate cancer as the percentage of participants who survived the prostrate cancer disease.
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
n=14 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 Participants
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
Disease Specific Survival
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 60 monthsClinical progression including local/regional and distant relapse is measured using Kaplan-Meier method
Outcome measures
| Measure |
Phase 1: SBRT- 45 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
n=14 Participants
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 Participants
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
Clinical Progression Including Local/Regional and Distant Relapse
|
1 number of participants
|
0 number of participants
|
0 number of participants
|
0 number of participants
|
Adverse Events
Phase 1: SBRT- 45 Gy
Phase 1: SBRT- 47.5 Gy
Phase 1: SBRT- 50 Gy
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: SBRT- 45 Gy
n=15 participants at risk
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 45 Gy in Phase 1
|
Phase 1: SBRT- 47.5 Gy
n=15 participants at risk
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 47.5 Gy in Phase 1
|
Phase 1: SBRT- 50 Gy
n=14 participants at risk
The dose of Stereotactic Body Radiation Therapy (SBRT) is - 50 Gy in Phase 1
|
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
n=47 participants at risk
The dose of SBRT is escalated- 50 Gy in Phase 2 stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2).
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary Frequency
|
26.7%
4/15 • 60 months
|
33.3%
5/15 • 60 months
|
57.1%
8/14 • 60 months
|
10.6%
5/47 • 60 months
|
|
Renal and urinary disorders
Urinary Urgency
|
20.0%
3/15 • 60 months
|
20.0%
3/15 • 60 months
|
7.1%
1/14 • 60 months
|
0.00%
0/47 • 60 months
|
|
Renal and urinary disorders
Cystitis
|
20.0%
3/15 • 60 months
|
6.7%
1/15 • 60 months
|
14.3%
2/14 • 60 months
|
4.3%
2/47 • 60 months
|
|
Renal and urinary disorders
Urinary Incontinence
|
6.7%
1/15 • 60 months
|
20.0%
3/15 • 60 months
|
0.00%
0/14 • 60 months
|
2.1%
1/47 • 60 months
|
|
Renal and urinary disorders
Hematuria
|
13.3%
2/15 • 60 months
|
0.00%
0/15 • 60 months
|
7.1%
1/14 • 60 months
|
2.1%
1/47 • 60 months
|
|
Renal and urinary disorders
Urinary Retention
|
6.7%
1/15 • 60 months
|
0.00%
0/15 • 60 months
|
0.00%
0/14 • 60 months
|
2.1%
1/47 • 60 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • 60 months
|
6.7%
1/15 • 60 months
|
7.1%
1/14 • 60 months
|
8.5%
4/47 • 60 months
|
|
Renal and urinary disorders
Bladder Ulcer
|
0.00%
0/15 • 60 months
|
0.00%
0/15 • 60 months
|
7.1%
1/14 • 60 months
|
0.00%
0/47 • 60 months
|
|
Renal and urinary disorders
Urethral Stricture
|
0.00%
0/15 • 60 months
|
0.00%
0/15 • 60 months
|
7.1%
1/14 • 60 months
|
0.00%
0/47 • 60 months
|
|
Gastrointestinal disorders
Rectal Toxicity
|
53.3%
8/15 • 60 months
|
53.3%
8/15 • 60 months
|
78.6%
11/14 • 60 months
|
70.2%
33/47 • 60 months
|
Additional Information
Dr. Robert Timmerman
University of Texas Southwestern Medical Center Dallas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place