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Clinical Trial Comparing 3-D RT vs. IMRT in Post- Prostatectomy Prostate Cancer Patients

NCT02678520 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-07-22

No results posted yet for this study

Summary

Compare the incidence of acute rectal, bladder and other acute toxicities between 3-D Conformal Radiation Therapy (RT/CRT) and Intensity Modulated Radiation Therapy (IMRT) in Post-Prostatectomy Prostate Cancer Patients treated with post-operative radiation therapy

Conditions

Interventions

RADIATION

3-D Conformal Radiation Therapy

Radiation delivered after surgery to remove the prostate, using 3-D Conformal Radiation Therapy. Radiation will be delivered to prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement. The total dose of radiation will be 6600 centigray (cGy) at 200 cGy/fraction (fx) given once daily .

RADIATION

Intensity Modulated Radiation Therapy

Radiation delivered after surgery to remove the prostate, using Intensity Modulated Radiation Therapy. Radiation will be delivered to prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement. The total dose of radiation will be 6600 centigray (cGy) at 200 cGy/fraction (fx) given once daily .

DRUG

Casodex, Zoladex , Lupron

Hormonal Therapy (6 Months): Required for "High Risk" Groups, and as per Standard of Care for "Low Risk" Groups. Hormonal therapy protocol regimen for the high risk "adjuvant" and "salvage" groups will consist of Casodex (50 mg/day po for 6 months) and Zoladex (10.8 mg subcutaneously once every 3 months x 2) or Lupron (22.5 mg given intramuscularly once every 3 months x 2 injections or 7.5 mg IM q once monthly x 6) to start on day 1 of the clinical trial. Hormonal therapy will typically begin 2 months prior to radiation and continue for a total of 6 months.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Parvesh Kumar, MD · University of Kansas Medical Center - Cancer Center

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

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 NCT02678520 on ClinicalTrials.gov