Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
Brief summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
Detailed description
OBJECTIVES: Primary * To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer. * To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity \< 10% and grade 3 rectal toxicity \< 10%). Secondary * To achieve adequate dosimetric coverage of the prostate comparable to current standards. * To assess the effect of treatment on sexual function. OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days. Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit. After completion of study treatment, patients are followed every 3 months for 1 year.
Interventions
OTHERquestionnaire administration
PROCEDUREquality-of-life assessment
RADIATIONbrachytherapy
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria: * PSA 10-20 ng/mL * Gleason score ≥ 7 * Stage ≥ T2b AND \< T3 * Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT) * Prostate size \< 60 cc by MRI or CT imaging * International Prostate Symptom Score Index ≤ 15
Exclusion criteria
* Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination) * Suspected extracapsular disease will not be considered an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity | At scheduled 3 month intervals for one year | Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity |
| Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity | Within 90 days of treatment (early toxicities) or after 90 days (late toxicities) | urinary and rectal toxicity-see the adverse event tables |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint | week 12 reported | Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26) |
| Median International Prostate Symptom Total Score | week 12 reported | Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HDR Brachytherapy 9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
questionnaire administration
quality-of-life assessment
brachytherapy | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not Treated | 2 |
Baseline characteristics
| Characteristic | HDR Brachytherapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 21 |
| serious Total, serious adverse events | 2 / 21 |
Outcome results
Primary
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity
Time frame: At scheduled 3 month intervals for one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDR Brachytherapy | Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity | 20 participants |
Primary
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
urinary and rectal toxicity-see the adverse event tables
Time frame: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDR Brachytherapy | Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity | 21 participants |
Other Pre-specified
Median International Prostate Symptom Total Score
Quality of life will be assessed with the MSKCC prostate quality of life instrument. International prostate symptom score index (IPSS). The IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning. This measure demonstrated a high internal consistency (Cronbach's alpha = 0.84) with excellent test-retest reliability (r = 0.92).
Time frame: week 12 reported
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HDR Brachytherapy | Median International Prostate Symptom Total Score | 5 scores on a scale |
Other Pre-specified
Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint
Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the number of participants who return to normal erectile function (IIEF-EF domain score ≥26)
Time frame: week 12 reported
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HDR Brachytherapy | Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint | 3 participants |