Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03748719|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
This study involves Stereotactic Body Radiation Therapy (SBRT) followed by prostatectomy (removal of the prostate). SBRT is a relatively new radiation technique in which a few doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The radiation will be given for only 5 days.
The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given before prostatectomy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Stereotactic Body Radiation Therapy (SBRT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer|
|Actual Study Start Date :||November 19, 2018|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2022|
Experimental: Stereotactic Body Radiation Therapy, followed by Prostatectomy
Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
Device: Stereotactic Body Radiation Therapy (SBRT)
- Measure of PSA (Prostate Specific Antigen) [ Time Frame: Up to 12 months ]Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
- Number of symptomatic adverse anastomotic events [ Time Frame: Up to 12 months ]Number of symptomatic anastomotic events related to pre-operative SBRT.
- Mean Catheterization Time [ Time Frame: Up to 4 weeks post surgery ]Average time of catheterization following prostatectomy
- Mean Hospital Stay [ Time Frame: Up to 2 week post surgery ]Average time of hospitalization after prostatectomy
- Quality of Life assessment [ Time Frame: Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery ]Quality of Life will be assessed using 2 questionnaires: International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM). The IPSS is an eight question questionnaire of symptoms ranging from 0 "not at all" to 5 "always". The SHIM is a five question questionnaire ranging from 1 "almost never or never" to 5 "almost always or always" to determine erectile dysfunction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748719
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Austin Lannon 813-745-2169 Austin.Lannon@moffitt.org|
|Principal Investigator: Peter Johnstone, MD|
|Principal Investigator: Julio Pow-Sang, MD|
|Sub-Investigator: Michael Poch, MD|
|Sub-Investigator: Brandon Manley, MD|
|Sub-Investigator: Javier Torres-Roca, MD|
|Sub-Investigator: Kosj Yamoah, MD, PhD|
|Sub-Investigator: Daniel Fernandez, MD, PhD|
|Principal Investigator:||Peter Johnstone, MD||H. Lee Moffitt Cancer Center and Research Institute|