Trial Outcomes & Findings for Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes (NCT NCT00214136)
NCT ID: NCT00214136
Last Updated: 2021-08-04
Results Overview
Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2021-08-04
Participant Flow
This study enrolled patients with high-risk prostate adenocarcinoma or radiographic evidence of pelvic lymph node involvement but absence of distal metastases from the Midwest. The last patient completed in February 2016.
All participants are assigned to the experimental arm.
Participant milestones
| Measure |
Experimental
Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Experimental
Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
|
|---|---|
|
Overall Study
Death
|
5
|
Baseline Characteristics
Intensity Modulated Radiation Therapy (IMRT) Radiotherapy for Treating Prostate Pelvic Nodes
Baseline characteristics by cohort
| Measure |
Experimental
n=30 Participants
Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
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
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
30 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
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
|
T stage
T1c
|
9 Participants
n=5 Participants
|
|
T stage
T2a
|
3 Participants
n=5 Participants
|
|
T stage
T2b,c
|
7 Participants
n=5 Participants
|
|
T stage
T3a,b
|
5 Participants
n=5 Participants
|
|
T stage
T4
|
1 Participants
n=5 Participants
|
|
T stage
Not reported
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Only 25 of 30 participants met the minimum follow up thresholds at the time of analysis; the 5 most recently accrued participants' data was not analyzed and is not reflected.
Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.
Outcome measures
| Measure |
Experimental
n=25 Participants
Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
|
|---|---|
|
Number of Participants Experiencing Expected Toxicities
|
13 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Data was not collected for this outcome measure. Results can not be reported or analyzed.
Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.
Outcome measures
Outcome data not reported
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 13 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental
n=25 participants at risk
Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy
|
|---|---|
|
Gastrointestinal disorders
Acute GI Grade 1
|
52.0%
13/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Gastrointestinal disorders
Acute GI Grade 2
|
32.0%
8/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Gastrointestinal disorders
Late GI Grade 1
|
20.0%
5/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Gastrointestinal disorders
Late GI Grade 2
|
8.0%
2/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Renal and urinary disorders
Acute GU Grade 1
|
52.0%
13/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Renal and urinary disorders
Acute GU Grade 2
|
40.0%
10/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Renal and urinary disorders
Late GU Grade 1
|
36.0%
9/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Renal and urinary disorders
Late GU Grade 2
|
20.0%
5/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
|
Renal and urinary disorders
Late GU Grade 3
|
4.0%
1/25 • Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria. Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored \> 90 days from the completion of radiation therapy for 5 years.
|
Additional Information
Dr. Mark A. Ritter
University of Wisconsin Carbone Cancer Center
Phone: 608-263-8500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place