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Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy (SBRT)
Prostatectomy
Quality of Life Questionnaires
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Stereotactic Body Radiation Therapy (SBRT), High Risk Prostate Cancer, Preoperative SBRT, Prostate Adenocarcinoma, Prostatectomy, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically-proven prostate adenocarcinoma.
  • Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
  • Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months.
  • Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA >20 ng/mL.
  • Prostate volume: ≤ 80 cc on transrectal ultrasound
  • IPSS score ≤15
  • Zubrod performance status 0-2 or equivalent
  • No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted.
  • No prior radiotherapy to the prostate or lower pelvis
  • 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 5 years
  • No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy
  • Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
  • Age ≥18 years
  • IPSS (AUA) score ≤15

Exclusion Criteria:

  • Does not have a diagnosis of prostate adenocarcinoma
  • Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN
  • Has stage N1 or M1 (metastatic) disease
  • Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization
  • Prostate volume greater than 80 cc on transrectal ultrasound
  • Zubrod performance status 3 or greater
  • Prior total prostatectomy or cryotherapy of the prostate
  • Prior radiation therapy to the pelvis
  • Implanted hardware which limits treatment planning or delivery (determined by the investigator).
  • Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers)
  • The use of androgen deprivation therapy (ADT) prior to registration or during radiation
  • Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
  • Unwilling or inability to give informed consent
  • Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires
  • IPSS score >15

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation of SBRT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Mean Catheterization Time for Study Participants
Mean catheterization time for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.
Mean Hospital Stay for Study Participants
Mean hospital stay for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.
Reoperation Rate for Study Participants
Mean reoperation rate for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2015
Last Updated
January 18, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02572284
Brief Title
Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer
Official Title
A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2016 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
October 23, 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

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Stereotactic Body Radiation Therapy (SBRT), High Risk Prostate Cancer, Preoperative SBRT, Prostate Adenocarcinoma, Prostatectomy, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation of SBRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy (SBRT)
Other Intervention Name(s)
radiation therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prostatectomy
Other Intervention Name(s)
surgery
Intervention Description
About 4-6 weeks after SBRT, participants will have a prostatectomy.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaires
Other Intervention Name(s)
questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dose Limiting Toxicity
Description
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.
Time Frame
Up to 28 ± 5 days post-prostatectomy
Secondary Outcome Measure Information:
Title
Occurrence of Late Toxicity
Description
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.
Time Frame
90+ days after start of radiotherapy
Title
Mean Catheterization Time for Study Participants
Description
Mean catheterization time for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.
Time Frame
Up to 18 months post surgery
Title
Mean Hospital Stay for Study Participants
Description
Mean hospital stay for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.
Time Frame
Up to 18 months post surgery
Title
Reoperation Rate for Study Participants
Description
Mean reoperation rate for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.
Time Frame
Up to 18 months post surgery
Title
Patient-Assessed Changes in Health-Related Quality of Life (HRQOL) - Expanded Prostate Cancer Index Composite (EPIC)
Description
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.
Time Frame
Up to 18 months post surgery
Title
Patient-Assessed Changes in HRQOL - International Prostate Symptom Score (IPSS)
Description
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.
Time Frame
Up to 18 months post surgery
Title
Patient-Assessed Changes in HRQOL - Rectal Assessment Scale (RAS)
Description
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.
Time Frame
Up to 18 months post surgery
Title
Patient-Assessed Changes in HRQOL - Sexual Health Inventory for Men (SHIM)
Description
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.
Time Frame
Up to 18 months post surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-proven prostate adenocarcinoma. Clinical stage ≤T3a based on digital rectal exam and/or ≤T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition) Prostate-specific antigen (PSA) ≤ 80 ng/ml, obtained within 3 months. Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group. High risk: Clinical stage T3a, or Gleason score = 8-10, or PSA >20 ng/mL. Prostate volume: ≤ 80 cc on transrectal ultrasound IPSS score ≤15 Zubrod performance status 0-2 or equivalent No prior total prostatectomy or cryotherapy of the prostate. Prior transurethral resection or laser ablation is permitted. No prior radiotherapy to the prostate or lower pelvis 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 5 years No androgen deprivation therapy (ADT) can be prescribed prior to or during radiation therapy Must be able to have gold fiducial markers placed in the prostate or, if patient already has fiducial markers placed, they must be in accordance with the protocol specifications Ability to understand and the willingness to sign a written informed consent document Willingness to fill out IPSS, SHIM, and EPIC quality of life forms Age ≥18 years IPSS (AUA) score ≤15 Exclusion Criteria: Does not have a diagnosis of prostate adenocarcinoma Has very low risk, low risk, intermediate risk or very high risk disease as defined by the NCCN Has stage N1 or M1 (metastatic) disease Has a PSA of greater than 80 ng/ml obtained no greater than 3 months prior to randomization Prostate volume greater than 80 cc on transrectal ultrasound Zubrod performance status 3 or greater Prior total prostatectomy or cryotherapy of the prostate Prior radiation therapy to the pelvis Implanted hardware which limits treatment planning or delivery (determined by the investigator). Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers) The use of androgen deprivation therapy (ADT) prior to registration or during radiation Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol Unwilling or inability to give informed consent Not willing to fill out IPSS, SHIM, and EPIC quality of life questionnaires IPSS score >15
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Johnstone, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio Pow-Sang, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website

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Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

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