Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2016
Start Date:July 2011

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Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial

This randomized phase III trial studies androgen-deprivation therapy and radiation therapy
in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer
cells. Androgen deprivation therapy may stop the adrenal glands from making androgens.
Radiation therapy uses high-energy x-rays to kill tumor cells.

PRIMARY OBJECTIVE:

I. Demonstrate that prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and
whole-pelvic radiation therapy (WPRT) will result in improvement in overall survival (OS) of
patients with "unfavorable" intermediate-risk or "favorable" high-risk prostate cancer
compared to NADT and high-dose prostate and seminal vesicle (SV) radiation therapy (prostate
[P] + SV radiation therapy [RT]) using intensity-modulated radiotherapy (IMRT) or
external-beam RT (EBRT) with a high-dose rate (HDR) or a permanent prostate (radioactive
seed) implant (PPI) boost.

SECONDARY OBJECTIVES:

I. Demonstrate that prophylactic WPRT improves biochemical control. II. Distant metastasis
(DM)-free survival. III. Cause-specific survival (CSS). IV. Compare acute and late
treatment-adverse events between patients receiving NADT and WPRT versus NADT + P and SV RT.

V. Determine whether health-related quality of life (HRQOL), as measured by the Expanded
Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness
of treatment (i.e., Arm 2, NADT + WPRT). (closed to patient accrual 3/9/15) VI. Determine
whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase
in fatigue (Patient-Reported Outcome Measurement Information System [PROMIS] Fatigue Short
Form) from baseline to last week of treatment, and a greater increase in circulating
inflammatory markers (interleukin [IL]-1, IL-1 receptor antagonist [ra], IL-6, tumor
necrosis factor [TNF]-alpha, and C-reactive protein). (closed to patient accrual 3/9/15)
VII. Demonstrate an incremental gain in OS and CSS with more aggressive therapy that
outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care,
usual activities, pain/discomfort, and anxiety/depression). (closed to patient accrual
3/9/15) VIII. Determine whether changes in fatigue from baseline to the next three time
points (week prior to RT, last week of treatment, and 3 months after treatment) are
associated with changes in circulating cytokines, mood, sleep, and daily activities across
the same time points.

IX. Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and
future translational research analyses.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally
(PO) once daily (QD) or flutamide PO thrice daily (TID) for 6 months, and luteinizing
hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate,
goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or
intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and
continuing for 6 or 32 months. Radiotherapy begins within 8-10 weeks after beginning LHRH
agonist/antagonist injection.

ARM I: Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using
IMRT* or 3D-conformal radiation therapy (3D-CRT)* QD, 5 days a week, for approximately 9
weeks. Patients may also undergo PPI brachytherapy or high-dose rate brachytherapy (iodine I
125 or palladium Pd 103 may be used as the radioisotope).

ARM II: Patients undergo WPRT* (3D-CRT or IMRT) QD, 5 days a week, for approximately 9
weeks. Patients may also undergo brachytherapy as in Arm I.

NOTE: * Patients undergoing brachytherapy implant receive 5 weeks of IMRT, 3D-CRT, or WPRT.

After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 3 years, and then yearly thereafter.

Inclusion Criteria:

- Pathologically (histologically or cytologically) proven diagnosis of prostatic
adenocarcinoma within 180 days of registration at moderate- to high-risk for
recurrence as determined by one of the following combinations:

- Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50
ng/mL (includes intermediate- and high-risk patients)

- Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >=
50% (positive) biopsies + PSA < 50 ng/ml

- Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL

- Patients previously diagnosed with low risk prostate cancer undergoing active
surveillance who are re-biopsied and found to have unfavorable intermediate risk
disease or favorable high risk disease according to the protocol criteria are
eligible for enrollment within 180 days of the repeat biopsy procedure

- 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

- Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal
computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or
dissection) within 90 days prior to registration

- Patients with lymph nodes equivocal or questionable by imaging are eligible if
the nodes are =< 1.5 cm

- No evidence of bone metastases (M0) on bone scan within 120 days prior to
registration (sodium fluoride [NaF] positron emission tomography [PET]/CT is an
acceptable substitute)

- Equivocal bone scan findings are allowed if plain films (or CT or magnetic
resonance imaging [MRI]) are negative for metastasis

- Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved
assay (e.g., Abbott, Hybritech) within 120 days prior to registration

- Study entry PSA should not be obtained during the following time frames:

- 10-day period following prostate biopsy

- Following initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

- Zubrod performance status 0-1 (unless otherwise specified)

- Absolute neutrophil count (ANC) >= 1,500/mm³

- Platelets >= 100,000/mm³

- Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention to
achieve Hgb >= 8.0 g/dL is acceptable)

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

Exclusion Criteria:

- Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a
minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of
the oral cavity is permissible; however, patients with prior history of bladder
cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma)
malignancy not allowed

- Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin,
buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g.,
flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol
[DES]), or surgical castration (orchiectomy)

- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the
onset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 days
prior to the date of registration

- Use of finasteride within 30 days prior to registration

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

- Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior
chemotherapy for a different cancer is allowable

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

- Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of
registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
or severe liver dysfunction

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for
Disease Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this
protocol; protocol-specific requirements may also exclude immuno-compromised
patients

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

- Prior allergic reaction to the hormones involved in this protocol

- Patients status post a negative lymph node dissection are not eligible
We found this trial at
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12200W. 110th Street
Overland Park, Kansas 66210
913.234.0400
Kansas City Cancer Centers - Southwest Through world-class research and patient care, The University of...
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Chapel Hill, North Carolina 27599
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
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University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
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301 University Blvd
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2500 N State St
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Jupiter, Florida 33458
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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4805 Northeast Glisan Street
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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620 John Paul Jones Cir
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Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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4502 Medical Drive
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9500 Gilman Dr
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808 North 39th Avenue
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1200 Old York Road
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818 Riverside Ave.
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1 Akron General Ave
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2000 E Greenville St
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
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5665 Peachtree Dunwoody Rd NE
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2000 Ogden Ave
Aurora, Illinois 60504
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155 5th St NE
Barberton, Ohio 44203
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1300 Anne Street NW
Bemidji, Minnesota 56601
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Billings, Montana 59101
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55 Fruit St
Boston, Massachusetts 02114
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506 6th St
Brooklyn, New York 11215
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171 Ashley Avenue
Charleston, South Carolina 29425
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1969 W Ogden Ave
Chicago, Illinois 60612
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Chicago, Illinois 60612
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272 Hospital Rd
Chillicothe, Ohio 45601
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
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10900 Euclid Ave
Cleveland, Ohio 44106
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Columbus, Georgia 31904
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
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Decatur, Illinois 62526
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2525 S Downing St
Denver, Colorado 80210
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Detroit, Michigan 48202
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22101 Moross Rd
Detroit, Michigan 48236
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2301 Erwin Rd
Durham, North Carolina 27710
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801 Broadway
Fargo, North Dakota 58102
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1255 Hwy 54 W,
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