Prostate Cancer
Conditions
Keywords
Radiation Therapy, Brachytherapy, 14-163
Brief summary
The purpose of this study is to test the safety and side effects of ultra-hypofractionated radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.
Interventions
RADIATIONexternal beam radiation therapy
RADIATIONbrachytherapy
BEHAVIORALquestionnaires
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as: * Pathologically-proven diagnosis of prostate adenocarcinoma * PSA 10-20ng/mL or * Gleason =7 or * Clinical stage T2b/c * Clinical stage T2b/c Additionally, patients will be required to meet the following criteria * Age ≥18 * KPS≥70 * Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician. * International Prostate Symptom Score ≤15
Exclusion criteria
* Prior prostate surgery (including TURP) * Prior history of chronic prostatitis or urethral stricture * Inflammatory bowel disease * Prior history of pelvic radiotherapy * Unable to give informed consent * Metastatic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0 | 12 months | Participants with Urinary Toxicity Assessed by CTCAE v4.0 at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months | 12 months | The International Prostate Symptom Score/IPSS index is a seven item questionnaire that assesses urinary functioning, including urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale. Higher scores indicate more difficulty in urinary functioning. A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic. Scale range is 0-35. Total score is reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiation Therapy in Combination With Brachytherapy Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy to the prostate & seminal vesicles. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not evaluable | 2 |
| Overall Study | Not Treated | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Radiation Therapy in Combination With Brachytherapy |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 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 | 6 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 45 |
| other Total, other adverse events | 33 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
Participants with Urinary Toxicity Assessed by CTCAE v4.0 at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiation Therapy in Combination With Brachytherapy | Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0 | 33 Participants |
Secondary
Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months
The International Prostate Symptom Score/IPSS index is a seven item questionnaire that assesses urinary functioning, including urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale. Higher scores indicate more difficulty in urinary functioning. A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic. Scale range is 0-35. Total score is reported.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy in Combination With Brachytherapy | Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months | 5 scores on a scale |