Prostate Cancer
Conditions
Brief summary
The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard short course IMRT of radiation (70 Gy at 2.5 Gy/fraction).
Interventions
RADIATIONradiotherapy
prostate radiation to 70Gy; nodal radiation to 56Gy
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer stage T-T3 * Predicted risk of lymph node involvement \> 15% * Gleason \> 7
Exclusion criteria
* Distance metastases * Use of anti-coagulant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Expected Toxicities | Up to 5 years | Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival | 5 years | Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All participants are assigned to the experimental arm.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
| T stage Not reported | 5 Participants |
| T stage T1c | 9 Participants |
| T stage T2a | 3 Participants |
| T stage T2b,c | 7 Participants |
| T stage T3a,b | 5 Participants |
| T stage T4 | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 25 |
| other Total, other adverse events | 13 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Participants Experiencing Expected Toxicities
Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities.
Time frame: Up to 5 years
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Number of Participants Experiencing Expected Toxicities | 13 Participants |
Secondary
To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival
Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals.
Time frame: 5 years
Population: Data was not collected for this outcome measure. Results can not be reported or analyzed.