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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:July 2011
End Date:July 2031

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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

RATIONALE: 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.

PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation
therapy in treating patients with prostate cancer.

OBJECTIVES:

Primary

- 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 (P) and seminal vesicle (SV) radiation
therapy (RT) using intensity-modulated RT (IMRT) or external-beam RT (EBRT) with a
high-dose rate (HDR) or a permanent prostate (radioactive seed) implant (PPI) boost.

Secondary

- Demonstrate that prophylactic WPRT improves biochemical control.

- Determine the distant metastasis (DM)-free survival.

- Determine the cause-specific survival (CSS).

- Compare acute and late treatment-adverse events between patients receiving NADT and WPRT
versus NADT, P, and SV RT.

- 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).

- Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a
greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of
treatment, and a greater increase in circulating inflammatory markers (IL-1, IL-1ra,
IL-6, tumor necrosis factor (TNF)-alpha, and C-reactive protein).

- 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).

- 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.

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

OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to
high-risk groups as listed in the Disease Characteristics of this abstract, type of
radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and
duration of androgen-deprivation therapy (short-term [6 months] vs long-term [32 months]).
Patients are randomized to 1 of 2 treatment arms.

All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally
(PO) once daily or flutamide PO thrice daily 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 weeks after beginning LHRH agonist/antagonist injection.

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

- Arm II: Patients undergo whole-pelvic radiotherapy (WPRT)* (3D-CRT or IMRT) once daily,
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.

Patients may undergo blood and urine sample collection for correlative studies. Primary tumor
tissue samples may also be collected.

Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue
Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and
periodically during treatment. Patients who participate in the QOL portion of the study must
also agree to periodic blood collection.

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

DISEASE CHARACTERISTICS:

- 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 and/or 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 CT
or 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

- Patients status post a negative lymph node dissection are not eligible

- No evidence of bone metastases (M0) on bone scan within 120 days prior to registration
(Na F PET/CT is an acceptable substitute)

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

- Baseline serum PSA value performed with an 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:

- Ten-day period following prostate biopsy

- Following initiation of hormonal therapy

- Within 30 days after discontinuation of finasteride

- Within 90 days after discontinuation of dutasteride

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

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

- Platelet count ≥ 100,000/mm³

- Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0
g/dL is acceptable)

- No prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for
a minimum of 3 years (1,095 days) and not in the pelvis

- E.g., carcinoma in situ of the oral cavity is permissible; however, patients with
prior history of bladder cancer are not allowed

- No prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy

- No previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No previous pelvic irradiation, prostate brachytherapy or bilateral orchiectomy

- No 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., 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.

- No severe, active co-morbidity, defined as any of the following:

- 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 (CDC) definition

- Protocol-specific requirements may also exclude immuno-compromised patients

- HIV testing is not required for entry into this protocol

- No patients who are sexually active and not willing/able to use medically acceptable
forms of contraception

- No prior allergic reaction to the hormones involved in this protocol

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

- No prior hormonal therapy, such as luteinizing hormone-releasing hormone (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)

- No prior pharmacologic androgen ablation for prostate cancer unless the onset of
androgen ablation is ≤ 45 days prior to the date of registration

- No finasteride within 30 days prior to registration

- No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- Prior chemotherapy for a different cancer is allowable

- No prior radiotherapy, including brachytherapy, to the region of the study cancer that
would result in overlap of radiation therapy fields
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2500 N State St
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2000 E Greenville St
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5301 McAuley Drive
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1968 Peachtree Rd NW
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55 Fruit St
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Carmichael, CA
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Cedar Rapids, Iowa 52402
Principal Investigator: Nagendra (Bobby) S. Koneru
Phone: 412-339-5294
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Cedar Rapids, IA
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Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-365-4673
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Cedar Rapids, IA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Chardon, Ohio 44024
Principal Investigator: Rodney J. Ellis
Phone: 800-641-2422
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Chardon, OH
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: David T. Marshall
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Chattanooga, Tennessee 37403
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Chattanooga, TN
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Thomas E. Lad
Phone: 312-864-5204
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Dian Wang
Phone: 312-942-5498
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Chicago, Illinois 60640
Principal Investigator: Stuart A. Krauss
Phone: 773-564-5032
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Chicago, IL
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Chicago, IL
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Principal Investigator: Timothy D. Moore
Phone: 877-779-7585
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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Chillicothe, OH
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Benjamin B. Bridges
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Clackamas, OR
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Clarkston, Michigan 48346
Principal Investigator: Frank A. Vicini
Phone: 248-338-0663
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Clarkston, MI
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5680 Bow Pointe Drive
Clarkston, Michigan 48346
Principal Investigator: Kiran Devisetty
Phone: 313-576-9790
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Clarkston, MI
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Rodney J. Ellis
Phone: 800-641-2422
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Principal Investigator: Andrew D. Vassil
Phone: 866-223-8100
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Andrew D. Vassil
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Clinton Township, Michigan 48038
Principal Investigator: Eleanor M. Walker
Phone: 313-916-1784
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Clinton Township, MI
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Cody, WY
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Coeur d'Alene, ID
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1400 East Boulder Street
Colorado Springs, Colorado 80909
Principal Investigator: Brian D. Kavanagh
Phone: 719-365-2406
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Colorado Springs, CO
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Columbia, Maryland 21044
Principal Investigator: Young Kwok
Phone: 443-546-1300
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Columbia, MD
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