Phase II Trial of SBRT + or - IMRT in Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

January 9, 2020 updated by: GenesisCare USA

A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Intensity Modulated Radiation Therapy (IMRT) in the Treatment of Patients With Clinically Confined Prostate Adenocarcinoma

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with locally confined prostate adenocarcinoma (clinical stage T1c - T2bN0M0, Gleason score 7, PSA 20 ng/ml) are assigned to one of two treatment arms. Low risk patients (T1c-T2a and PSA <10 ng/ml and Gleason Score 6 or less) will receive 5 fractions of 8.0 Gy for a total of 40 Gy. Intermediate risk patients (T2b or PSA >10 ng/ml orGleason Score 7) will receive 1.8 Gy of IMRT for 25 fractions over 5 weeks for a total of 45 Gy. They will then receive a boost consisting of 4, 5.5 Gy fractions after IMRT for a total of 22 Gy. All patients will be assessed for toxicity at periodic time points following completion of treatment.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Myers, Florida, United States, 33907
        • 21st Century Oncology
      • Plantation, Florida, United States, 33324
        • 21st Century Oncology
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • 21st Century Oncology
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29577
        • Century Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically determined adenocarcinoma is required.
  • All other histologies are excluded.
  • Tissue for diagnosis must be obtained by transrectal ultrasound biopsy.
  • Gleason scoring classification of the biopsy specimen is required and must be greater than or equal to 7.
  • 2002 AJCC clinical cancer stage as determined by either urologist or radiation oncologist must be T1c - T2b, N0, M0.
  • N0 stage may be assigned following either negative imaging or negative pathologic assessment.
  • Prostate volume as assessed by TRUS must be less than 60 cc. 3.1.5.
  • PSA must be less than 20 ng/ml. ,
  • Age ≥ 18,
  • IPSS voiding symptoms score must be less than 18,
  • Study consent form must be signed by the patient.

Exclusion Criteria:

  • Gleason score of 8 - 10,
  • Clinical stage T3 - T4,
  • Age ≤ 18,
  • Any evidence of nodal (N1) or distant (M1) disease,
  • Prostate volume as assessed by TRUS > 60 cc,
  • PSA > 20 ng/ml,
  • IPSS voiding symptoms score > 18,
  • Prior TURP,
  • Prior pelvic radiotherapy or chemotherapy,
  • Prior prostatectomy,
  • Prior cancer other than basal cell or squamous cell skin carcinoma unless free of disease for > 5 years,
  • Current medical or psychiatric illness that may interfere with treatment completion and followup,
  • Hip prosthesis,
  • Unable or unwilling to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SBRT only
Patients assigned to this arm receive 8.0 Gy per fraction for 5 fractions for a total of 40 Gy
Radiation: SBRT
8.0 Gy per fraction for 5 fractions for a total of 40 Gy
Other Names:
  • SBRT only
Active Comparator: IMRT plus SBRT Boost
Patients assigned to this arm receive 1.8 Gy per fraction for 25 fractions over 5 weeks for a total of 45.0 Gy followed by an SBRT boost of 5.5 Gy per fraction for 4 fractions after IMRT for a total of 22.0 Gy
Radiation: SBRT
8.0 Gy per fraction for 5 fractions for a total of 40 Gy
Other Names:
  • SBRT only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the rate of chronic grade 3 - 5 genitourinary (GU) and gastrointestinal (GI) toxicity of SBRT either as a boost following conventionally fractionated IMRT or as a monoradiotherapy
Time Frame: Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years.
At baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. After the third year after therapy completion, follow-up visits will be annually for life, up to 10 years.
Periodical (baseline, during treatment, and at 1 month, 3 months, 6 months, 9 months, and 12 months post treatment. For the second and third years after therapy completion, follow-up visits will be every 6 months. Then annually for ____ years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenesisCare USA

Investigators

  • Principal Investigator: Constantine Mantz, MD, GenesisCare USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21C-2006-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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