Two different types of radiotherapy, and hormone therapy for treatment of prostate cancer

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"SBRT boost (high doses of radiation to tumor ), IMRT (low radiation to normal tissues, optimal radiation to cancer cells), hormone therapy"
Age:
18 to 100 years old
Gender:
Male
Healthy Volunteers:
No
Keywords:
prostate, prostate cancer, cancer, radiotherapy, radiation
Type:
Radiation study
Investigator:
Description
The purpose of this study is to find out the side effects and effectiveness of stereotactic body radiotherapy (SBRT) boost in patients with intermediate and high risk prostate cancer when used with intensity modulated radiotherapy (IMRT) and hormone therapy.
SBRT boost is a treatment method used to deliver high doses of radiation to the tumor in your prostate. This will require placement of transponders called permanent Beacon transponders®. Beacon transponders®, used with the Calypso® 4D Localization System™, have been approved by the U.S. Food and Drug Administration for use in the prostate. The transponders work with the Calypso® system to track the exact location of your prostate tumor.
Standard radiation techniques cannot avoid delivering radiation to normal tissues that do not need to get radiation. IMRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to your cancer and to areas that the study doctor thinks may have cancer cells, such as lymph nodes in the pelvis. IMRT does this by using multiple, computer-controlled radiation beams aimed at your cancer from different directions.
Hormone therapy is standard of care for your cancer and works by lowering the levels of testosterone in the body, which are naturally occurring male hormones. Testosterone is involved in the growth of cancer cells in the prostate. Drugs that reduce or block testosterone (hormone therapy) can cause some prostate cancer cells to die and others to become sick so that they don’t grow. Some patients treated with a combination of these drugs and radiation therapy have a greater chance of not having the cancer return when compared to men treated with radiation alone. You will take injections of a luteinizing hormone releasing hormone (LHRH) agonist, either under the skin or in the muscle , and you will take a pill, bicalutamide once per day.
The injected LHRH agonists (otherwise known as Lupron® and Zoladex® - your radiation oncologist will decide which one of these you will receive) is a drug which reduces the amount of testosterone in the body. Prostate cancer cells are hormone dependent. This means they need hormones (testosterone) to grow. By blocking the formation of testosterone, LHRH agonists block the formation of more cancer cells. The pill, Casodex®, will interfere with the action of any remaining testosterone. Casodex® will do this by binding to the prostate instead of testosterone and therefore blocking the growth of more cancer cells.
This study requires
History and physical
Blood tests
Weights
Assessment of your ability to carry out activities of daily living
PSAs
Hormone and radiation therapies
Who can participate?
Inclusion Criteria:

1. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence

2. History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.

3. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.

4. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.

5. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.

6. Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.

7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.

8. Study entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.

9. Zubrod Performance Status 0-2

10. CBC/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function

11. Patient must be able to provide study specific informed consent prior to study entry.


Exclusion Criteria:

1. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.

2. Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

3. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

4. Previous hormonal therapy

5. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.

6. Use of finasteride within 30 days prior to registration

7. Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

8. Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1.

9. Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

10. Severe, active co-morbidity including heart issues, infection and liver problems

11. Patients who are sexually active and not willing/able to use medically acceptable forms of contraception

12. Prior allergic reaction to the hormones involved in this protocol

13. Patients status-post a negative lymph node dissection are not eligible
Resources
Schedule
Study duration and period
Treatment: Variable Follow up: Visit every six months for three years, and then once a year for two years
Recruitment period
From March 6, 2013
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Heather Melanson
Research Topic
Conditions:
  • Adenocarcinoma of the Prostate

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