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The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy. Depending when participants enter the study, they will be treated with either 5 or 6 gray (Gy) per day of radiation. A Gy is a measure of radiation dose. The standard dose is 10Gy per day when SBRT is the only treatment to the prostate and no surgery is planned. The researchers want to see which dose of radiation will work best with the least amount of side effects. About 4-6 weeks after SBRT, participants will have a prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation of SBRT | Experimental | Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy and Quality of Life questionnaires. The radiation will be given for only 5 days. Conventional radiation to the prostate is given over 7-8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | The first group of patients to enter the study will receive 5 Gy of SBRT per day for 5 days, the second group will receive 6 Gy per day for 5 days. Each treatment will take about 3 minutes and be given as an outpatient at Moffitt Cancer Center. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity | Acute dose-limiting toxicity and quality of life due to preoperative SBRT followed by robotic-assisted laparoscopic radical prostatectomy at 14 ± 5 days and 28 ± 5 days post-prostatectomy in high risk prostate cancer patients. In order to assess the toxicity of preoperative SBRT, the severity of specific events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 form where a score of ≥3 is considered dose-limiting. | Up to 28 ± 5 days post-prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Late Toxicity | Late (defined as occurring more than 90 days after the start of radiotherapy) toxicity that is grade 2 or more as defined by the Common Terminology Criteria for Adverse Events version 4. | 90+ days after start of radiotherapy |
| Mean Catheterization Time for Study Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Johnstone, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Julio Pow-Sang, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D011878 | Radiotherapy |
| D011468 | Prostatectomy |
| D013514 | Surgical Procedures, Operative |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D008919 | Investigative Techniques |
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|
|
| Prostatectomy | Procedure | About 4-6 weeks after SBRT, participants will have a prostatectomy. |
|
|
| Quality of Life Questionnaires | Other | Patient assessed health-related quality of life (HRQOL). Quality of Life (QOL) will be assessed using Prostate Symptom Score (IPSS), rectal assessment scale (RAS), sexual health inventory for men (SHIM), and Expanded Prostate Cancer Index Composite (EPIC) patient questionnaires: administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. |
|
|
Mean catheterization time for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy. |
| Up to 18 months post surgery |
| Mean Hospital Stay for Study Participants | Mean hospital stay for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy. | Up to 18 months post surgery |
| Reoperation Rate for Study Participants | Mean reoperation rate for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy. | Up to 18 months post surgery |
| Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC) | Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The 26-item, short-form version of the Expanded Prostate Cancer Index Composite (EPIC) is a validated questionnaire used to assess HRQOL in prostate cancer patients. EPIC includes 4 domains: urinary, bowel, sexual, and hormonal. There are summary, i.e., overall, scores and function and bother subscale scores for each of the 4 domains. The urinary domain has 2 additional subscales: incontinence and irritative/obstructive. Domains and subscales are scored using a 0-100 grading system, with a higher score indicating a better quality of life. | Up to 18 months post surgery |
| Patient-Assessed Changes in HRQOL - International Prostate Symptom Score (IPSS) | Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The IPSS will be used to assess changes in urinary toxicity. Scoring is 0, 1, 2, 3, 4, 5 per question, Total IPSS Score out of 35 points from 7 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations. | Up to 18 months post surgery |
| Patient-Assessed Changes in HRQOL - Rectal Assessment Scale (RAS) | Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The RAS will be used to assess changes in rectal toxicity. Scoring is 0, 1, 2, 3 per question, Total RAS Score out of 15 points from 5 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations. | Up to 18 months post surgery |
| Patient-Assessed Changes in HRQOL - Sexual Health Inventory for Men (SHIM) | Administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy. The SHIM will be used to assess changes in sexual toxicity. Scoring is 0, 1, 2, 3, 4, 5 per question, Total SHIM score out of 25 points from 5 questions. Descriptive summaries of scores at baseline and each subsequent follow up will include means and standard deviations. | Up to 18 months post surgery |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013521 |
| Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |