Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring High Risk Prostate Cancer, prostate, radiation therapy
Eligibility Criteria
- Histologically proven prostate adenocarcinoma.
- Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm.
- PSA ≤ 50 ng/ml, obtained within 3 months
- Prostate volume: ≤60 cc.
- IPSS score ≤15.
- No previous radiotherapy to the prostate or lower pelvis.
- Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
- No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
- No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
- Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to fill out quality of life questionnaires.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic Body Radiation Therapy, followed by Prostatectomy
Arm Description
Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
Outcomes
Primary Outcome Measures
Measure of PSA (Prostate Specific Antigen)
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
Number of symptomatic anastomotic events related to pre-operative SBRT.
Secondary Outcome Measures
Mean Catheterization Time
Average time of catheterization following prostatectomy
Mean Hospital Stay
Average time of hospitalization after prostatectomy
Quality of Life assessment
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.
Full Information
NCT ID
NCT03748719
First Posted
November 19, 2018
Last Updated
May 22, 2020
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03748719
Brief Title
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Official Title
A Single Arm Phase II Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual interest
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
High Risk Prostate Cancer, prostate, radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Body Radiation Therapy, followed by Prostatectomy
Arm Type
Experimental
Arm Description
Patients will receive 6 Gy per day of Stereotactic Body Radiation Therapy (SBRT) per day for 5 days, followed by prostatectomy in 3 weeks.
Intervention Type
Device
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
SBRT treatment
Primary Outcome Measure Information:
Title
Measure of PSA (Prostate Specific Antigen)
Description
Measure of PSA through treatment. PSA is expected to be undetectable (<0.2 mg/ml) after prostatectomy and radiation therapy.
Time Frame
Up to 12 months
Title
Number of symptomatic adverse anastomotic events
Description
Number of symptomatic anastomotic events related to pre-operative SBRT.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Mean Catheterization Time
Description
Average time of catheterization following prostatectomy
Time Frame
Up to 4 weeks post surgery
Title
Mean Hospital Stay
Description
Average time of hospitalization after prostatectomy
Time Frame
Up to 2 week post surgery
Title
Quality of Life assessment
Description
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.
Time Frame
Baseline, at 2 weeks, 4 weeks, 2 months and every 3 months up to 12 months post surgery
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Histologically proven prostate adenocarcinoma.
Clinical stage ≤T3a based on digital rectal exam (DRE) and ≤T3a based on MRI (within 3 months); N0-Nx; M0-Mx, or Gleason score 4 + 4. No more than 1 lymph node >1 cm.
PSA ≤ 50 ng/ml, obtained within 3 months
Prostate volume: ≤60 cc.
IPSS score ≤15.
No previous radiotherapy to the prostate or lower pelvis.
Lymph node risk of <35% using https://www.mskcc.org/nomograms/prostate/pre_op.
No prior radical prostatectomy or cryotherapy of the prostate (prior transurethral resection or laser ablation are permitted).
No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
No history of an invasive malignancy (other than this prostate cancer, or non-metastatic basal or squamous skin cancers) in the last 3 years.
No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy.
Participant must be able to have gold fiducial markers placed in the prostate. Note: patients can be enrolled after fiducial markers have been placed, as long as the procedure was done in accordance with the protocol (Section 4.2.2).
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Ability to understand and the willingness to sign a written informed consent document.
Willing to fill out quality of life questionnaires.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Johnstone, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials Website
Learn more about this trial
Single Arm Trial of Preoperative Stereotactic Body Radiation Therapy (SBRT) for T3a or Gleason Grade Group 4 Prostate Cancer
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