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Randomized Trial of External Beam Radiation With or Without Short-Course Hormonal Therapy in Intermediate Risk Prostate Cancer Patients


Phase 3
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Randomized Trial of External Beam Radiation With or Without Short-Course Hormonal Therapy in Intermediate Risk Prostate Cancer Patients


Prior patient studies have shown that short-term hormone therapy (about 4 months) before and
during radiation therapy can benefit patients with bulky tumors or locally-advanced prostate
tumors. These prior results have been used to justify a potential benefit for using
short-term hormone therapy combined with radiation therapy for patients with less bulky or
less advanced prostate cancers. However, the combination of hormone therapy and radiation
has not been shown to definitively benefit patients with your level of prostate cancer.
Furthermore, these older studies used relatively low doses of radiation by today's
standards, and hormone therapy may be of no benefit when using higher doses of radiation.
Researchers want to study the use of combination hormone therapy and radiation therapy in
the treatment of your level of prostate cancer.

If you are eligible to take part in this study, you will be randomly assigned (as in the
toss of a coin) to one of 2 treatment groups. There is an equal chance of being assigned to
either treatment group.

If you are assigned to Group 1, you will receive high-dose radiation treatment given over
about 8 1/2 weeks. During this period, you will receive up to 42 treatments, 5 days per week
with 2 days rest in between. There will be no treatment on weekends. This is the current
standard schedule of treatment for prostate cancer patients. A radiation treatment planning
session will be done before the actual radiation treatments. This planning session will be
used to get images of your prostate and other pelvic organs to help plan the radiation
fields. The planning session involves a computed tomography (CT) scan that takes about
40-45 minutes. During this time, about 3 special, permanent tattoo marks will be placed on
your skin using ink. The tattoo marks will help with daily setup and positioning of the
radiation fields. These marks are small and about the size of a freckle.

If you are assigned to Group 2, you will receive the same radiation therapy as participants
in Group 1, but you will also receive hormone therapy with bicalutamide (Casodex) and either
leuprolide (Lupron) or goserelin (Zoladex). The hormone therapy includes a total of 2
injections or shots (leuprolide or goserelin) given every 3 months and a pill (bicalutamide)
that is taken once per day for the first 21 to 30 days. Flutamide, which is taken three
times per day for the first 21-30 days, may be used instead of bicalutamide. The choice of
hormone therapy will be left up to your treating physician. You will receive hormone
therapy for a full 6 months. Hormonal treatment will begin about 2 months before radiation
therapy is due to start and continue for 2 months during radiation therapy, with the last
phase of hormone treatment for 2 months after radiation therapy.

No matter which group you are assigned to, you will be given questionnaires to study
health-related quality of life. These questionnaires will take about 15 minutes to complete
and will be given to you before therapy begins. Within 1-2 weeks before starting radiation
therapy, you will answer a health-related quality of life questionnaire (Expanded Prostate
Cancer Index Composite-SF12-AUASI). Participants who are receiving hormonal therapy will
also be given this questionnaire within one week before hormonal therapy. During
radiotherapy, you will be examined every week, and severe side effects and reactions will be
recorded using the modified acute toxicity scale. During radiotherapy, you also will be
given the EPIC-26 Short Form at Weeks 4 and 8.

After you finish radiation therapy, you will be given the EPIC-SF12-AUASI every 3 months for
the first year, every 6 months for the next 2 years, and then once a year after that. This
may be done in person, by phone or by mail.

Prostate specific antigen (PSA) and testosterone levels will be checked before therapy
begins. These blood tests will require about 1 teaspoon of blood. They will be checked
before radiation therapy begins, but will not be checked during your radiation treatment.
Your PSA and testosterone levels will be rechecked at 3 to 6 month intervals after the
radiation therapy is done for the first 2 years. PSA will be checked every 6 months for the
Years 3 and 4, and once a year for Year 5.

If you have worsening of disease or have intolerable side effects, you may elect to remove
yourself from the prescribed treatment, but you may still be followed as part of the study.

You will be asked to return for follow-up testing in the form of physical exam every 6
months for the first 2 years and once each year after that. The purpose of the follow-up
visits and tests is to check the response of your cancer to treatment. If the PSA or
physical exam shows that the disease has not gone away completely or has come back, you may
have repeat staging with a bone scan, pelvic CT or magnetic resonance imaging (MRI), and
repeat prostate biopsy.

You will be watched for the condition of your disease for at least 4-5 years with follow-up
visits and PSA tests. If you are willing to return for follow-up visits beyond 5 years,
then you will continue to receive long term follow-up and be observed and advised about your
illness, according to your individual needs.


Inclusion Criteria:



1. Biopsy proven prostate cancer within last 12 months. Pathology must be reviewed at
M.D. Anderson Cancer Center (MDACC).

2. 1992 American Joint Committee on Cancer (AJCC) clinical stage T1c-2b on digital
rectal exam with biopsy Gleason sum of 7 and Prostate-Specific Antigen (PSA) < 20
ng/mL (i.e. PSA 19.99 ng/mL or less)

3. 1992 AJCC clinical stage T2b on physical exam with biopsy Gleason sum of 7 or
less and/or PSA < 20 ng/ml

4. 1992 AJCC clinical stage T1c-2b on digital rectal exam with biopsy Gleason sum of 7
or less and PSA > 10 but less than 20 ng/ml (i.e. 10.01-19.99 ng/mL). PSA used for
protocol eligibility should be obtained within 30 days of protocol enrollment.

5. No evidence of metastatic disease on bone scan within 3 months of study enrollment.

6. No evidence of metastatic disease on pelvic computed tomography (CT) or magnetic
resonance imaging (MRI) within 3 months of study enrollment.

7. Zubrod performance status < 2.

8. Must be able to understand protocol and adhere to follow-up initially at 3 months
post-radiation and then at 6 month intervals for first two years and annually
thereafter.

9. Patient must be able to undergo adequate daily trans-abdominal ultrasound
localization (B.A.T.) or other image-guided localization of the prostate during
radiation course.

10. Patients will be allowed to participate in other protocols if they are eligible and
the other protocols do not interfere with participation in this protocol.

Exclusion Criteria:

1. Patients who do not meet the inclusion criteria. Specifically, patients with all the
following features: clinical T1c-2a and Gleason sum of 6 and PSA Patients with one or more of the following features: clinical T2c, or Gleason 8-10,
or PSA > 20 ng/ml are not eligible.

2. Prior androgen suppression therapy. (Prior finasteride and saw palmetto allowed but
must be discontinued prior to enrollment. Biopsy and PSA must be documented prior to
finasteride use.)

3. Previous or concurrent malignancies other than basal or squamous cell skin cancers
unless disease-free for 5 years or more.

4. Prior pelvic radiation or chemotherapy. Patients who received chemotherapy for
non-prostate cancer malignancies over 5 years prior will be eligible.

5. Prior or planned radical prostate surgery.

6. Patients with clinical evidence or biopsy-proven extracapsular extension, seminal
vesicle involvement, or lymph node involvement will be excluded. Patients with
radiographic evidence of nodal or bone metastasis will be excluded.

7. Other histologies such as small cell carcinoma, sarcomatoid or ductal variants are
not eligible.

8. Patients with any Gleason grade 5 disease on biopsy will not be eligible.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prostate Specific Antigen (PSA) Failures

Outcome Description:

Baseline + Post-radiation PSA levels at three month intervals for initial two years then every 6 months thereafter. Participants with a rising PSA and no evidence of local or distant recurrence considered PSA failures.

Outcome Time Frame:

3 months up to 2 years

Safety Issue:

No

Principal Investigator

Andrew K. Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0819

NCT ID:

NCT00388804

Start Date:

February 2005

Completion Date:

April 2011

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • External Beam Radiotherapy
  • Radiation Therapy
  • Hormone Therapy
  • Bicalutamide
  • Casodex
  • Leuprolide
  • Lupron
  • Goserelin
  • Zoladex
  • Flutamide
  • EBRT
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030