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Dose Escalation Study of Preoperative SBRT for High Risk Prostate Cancer

NCT02572284 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-01-19

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

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.

PROCEDURE

Prostatectomy

About 4-6 weeks after SBRT, participants will have a prostatectomy.

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Peter Johnstone, M.D. · H. Lee Moffitt Cancer Center and Research Institute

  • Julio Pow-Sang, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2018-07-05
Completion
2019-10-23

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02572284 on ClinicalTrials.gov