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Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

This study is currently recruiting participants.
Verified October 2017 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02572284
First Posted: October 8, 2015
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  Purpose
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, 6 or 7 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.

Condition Intervention
Prostate Cancer Radiation: Stereotactic Body Radiation Therapy (SBRT) Procedure: Prostatectomy Other: Quality of Life Questionnaires

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Preoperative Stereotactic Body Radiation Therapy (SBRT) for High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Dose Limiting Toxicity [ Time Frame: Up to 28 ± 5 days post-prostatectomy ]
    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 [ Time Frame: 90+ days after start of radiotherapy ]
    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 [ Time Frame: Up to 18 months post surgery ]
    Mean catheterization time for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.

  • Mean Hospital Stay for Study Participants [ Time Frame: Up to 18 months post surgery ]
    Mean hospital stay for study participants, compared to existing mean statistics for robotic-assisted laparoscopic radical prostatectomy.

  • Reoperation Rate for Study Participants [ Time Frame: Up to 18 months post surgery ]
    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) [ Time Frame: Up to 18 months post surgery ]
    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) [ Time Frame: Up to 18 months post surgery ]
    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) [ Time Frame: Up to 18 months post surgery ]
    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) [ Time Frame: Up to 18 months post surgery ]
    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.


Estimated Enrollment: 9
Actual Study Start Date: October 7, 2015
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Escalation of SBRT
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.
Radiation: Stereotactic Body Radiation Therapy (SBRT)
The first group of patients to enter the study will receive 5Gy of SBRT per day for 5 days, the second group will receive 6Gy per day for 5 days and the third group will receive 7Gy per day for 5 days. Each treatment will take about 3 minutes and be given as an outpatient at Moffitt Cancer Center.
Other Name: radiation therapy
Procedure: Prostatectomy
About 4-6 weeks after SBRT, participants will have a prostatectomy.
Other Name: surgery
Other: Quality of Life Questionnaires
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.
Other Name: questionnaire

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02572284


Locations
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   
Contact: Peter Johnstone, M.D.    813-745-8424    peter.johnstone@moffitt.org   
Principal Investigator: Peter Johnstone, M.D.         
Principal Investigator: Julio Pow-Sang, M.D.         
Sub-Investigator: Jasreman Dhillon, M.D.         
Sub-Investigator: Daniel Fernandez, M.D., Ph.D.         
Sub-Investigator: Jae Lee, Ph.D.         
Sub-Investigator: Michael Poch, M.D.         
Sub-Investigator: Javier Torres-Roca, M.D.         
Sub-Investigator: Amber Orman, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02572284     History of Changes
Other Study ID Numbers: MCC-18201
First Submitted: October 7, 2015
First Posted: October 8, 2015
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Stereotactic Body Radiation Therapy (SBRT)
High Risk Prostate Cancer
Preoperative SBRT
Prostate Adenocarcinoma
Prostatectomy
Quality of Life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases