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Trial record 2 of 67 for:    Recruiting Studies | Prostate Cancer | Florida, United States

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
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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)
SBRT treatment




Primary Outcome Measures :
  1. 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.

  2. Number of symptomatic adverse anastomotic events [ Time Frame: Up to 12 months ]
    Number of symptomatic anastomotic events related to pre-operative SBRT.


Secondary Outcome Measures :
  1. Mean Catheterization Time [ Time Frame: Up to 4 weeks post surgery ]
    Average time of catheterization following prostatectomy

  2. Mean Hospital Stay [ Time Frame: Up to 2 week post surgery ]
    Average time of hospitalization after prostatectomy

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
  • 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 <20% 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.

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): NCT03748719


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   
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         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Peter Johnstone, MD H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03748719     History of Changes
Other Study ID Numbers: MCC-19670
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
High Risk Prostate Cancer
prostate
radiation therapy

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