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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00667888
First received: April 24, 2008
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

Treatment: 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

Objectives:

  1. To assess the efficacy of 72 Gy in 30 fractions HIMRT (85 Gy BED assuming an alpha/beta of 1.5) relative to 75.6 Gy in 42 fractions CIMRT. The main end point will be the incidence of a rising PSA. Information on local control, freedom from distant metastasis and overall survival will also be acquired.
  2. To establish local failure by biopsy of the prostate when objective tests (PSA, ultrasound, DRE) suggest relapse.
  3. To determine the rates of late side effects at 2, 3, 4 and 5 years post-treatment using questionnaires to assess bladder, rectal, and sexual function.
  4. To obtain the pretreatment prostate biopsy material to assess prospectively the predictive value of various potential prognostic factors, such as, p53, bcl-2, bax and Ki-67.
  5. To assess the prognostic value of pretreatment serum testosterone, sex hormone binding globulin, and estradiol.

Condition Intervention Phase
Prostate Cancer
 Radiation: Conventional Fractionated Intensity Modulated Radiotherapy
Radiation: Hypofractionated Intensity Modulated Radiotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Intensity Radiotherapy Dose Escalation for Prostate Cancer Using Hypofractionation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Incidence of Rising PSA [ Time Frame: PSA every 3 months for the first 2 years; every 6 months for years 3-5; and yearly thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 225
Study Start Date: January 2001
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IMRT
Intensity Modulated Radiotherapy (IMRT)
 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 Name: IMRT
Experimental: HIMRT
Hypofractionated Intensity Modulated Radiotherapy (HIMRT)
 Radiation: Hypofractionated Intensity Modulated Radiotherapy
A total dose of 72 Gy will be delivered in 30 fractions to the PTV.
Other Name: HIMRT

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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667888

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Deborah A. Kuban, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00667888     History of Changes
Other Study ID Numbers: ID00-381
Study First Received: April 24, 2008
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Radiation
Radiotherapy
Intensity Modulated Radiotherapy
 IMRT
Hypofractionated Intensity Modulated Radiotherapy
HIMRT

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

ClinicalTrials.gov processed this record on June 18, 2013