A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

January 4, 2021 updated by: M.D. Anderson Cancer Center
The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance of being in either group.

Patients in Group 1 will be treated with intensity modulated radiotherapy (IMRT). These patients will receive 42 treatments, 5 days per week, over 8.5 weeks. This method has become the standard treatment at M.D. Anderson Cancer Center.

Patients in Group 2 will also be treated with IMRT. However, these patients will only receive 30 treatments, 5 days per week, over 6 weeks. The dose per day for Group 2 patients is higher than for Group 1 and has the possibility of killing more tumor cells.

Each external beam treatment requires about 10-20 minutes. However, patients can expect to spend 20 - 30 minutes on the treatment table because imaging measurements of prostate position will be done before each treatment. The total time in the radiation department each treatment day will be about an hour.

After the radiotherapy is completed, patients will have a PSA blood test every 3 months for 2 years, then every 6 months for Years 3 - 5, then annually. They will be examined every 6 months during the first 2 years beginning 3 months after the completion of treatment, then annually. A needle biopsy of the prostate will be performed if these tests suggest recurrence.

This is an investigational study. 225 patients will take part in this study. This study will take place at M. D. Anderson and possibly some affiliated hospitals.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 3

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
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Biopsy proof of adenocarcinoma of the prostate.
  2. Bone scan (If PSA >10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
  3. CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
  4. Suitable medical condition; Zubrod <2.
  5. Pretreatment PSA </=20 ng/ml. If PSA <4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
  6. Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
  7. While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score <8 and pretreatment PSA less than or equal to 10 ng/ml
  8. Gleason score <10.
  9. If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
  10. The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
  11. Informed consent must be given.
  12. Patients randomized to Arm 1 may also participate in protocol 2004-0428.

Exclusion Criteria:

  1. Prior pelvic radiotherapy.
  2. Greater than 4 months of prior hormone ablation therapy.
  3. Prior or planned radical prostate surgery.
  4. Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
  5. Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
  6. Zubrod status greater than or equal to 2.
  7. Pretreatment PSA >20 ng/ml.
  8. Gleason score of 10.
  9. Palpable stage T3c (seminal vesicle involvement) or T4 disease.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intensity Modulated Radiotherapy (IMRT)
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
Radiation: Conventional Fractionated Intensity Modulated Radiotherapy
A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).
Other Names:
  • IMRT
EXPERIMENTAL: Hypofractionated Intensity Modulated Radiotherapy (HIMRT)
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
Radiation: Hypofractionated Intensity Modulated Radiotherapy
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
Other Names:
  • HIMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)
Time Frame: 8.5 years
To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.
8.5 years

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (ACTUAL)

January 3, 2001

Primary Completion (ACTUAL)

October 12, 2015

Study Completion (ANTICIPATED)

October 1, 2021

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 25, 2008

First Posted (ESTIMATE)

April 28, 2008

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID00-381
  • NCI-2010-01456 (REGISTRY: NCI CTRP)

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.

Subscribe