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 |
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.
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.
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
290
sites
12200W. 110th Street
Overland Park, Kansas 66210
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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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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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
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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University of California at San Diego UC San Diego is dedicated to the advancement of...
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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Akron General Medical Center It
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161 North Forge Street
Akron, Ohio 44304
Akron, Ohio 44304
(330) 375-7280
Summa Center for Cancer Care at Akron City Hospital Summa Health System is a leader...
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170 North 1100 East
American Fork, Utah 84003
American Fork, Utah 84003
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McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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13001 E. 17th Pl.
Aurora, Colorado 80045
Aurora, Colorado 80045
303-724-5000
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Summa Barberton Hospital Summa Barberton Hospital is a full member of Summa Health System and...
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Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Massachusetts General Hospital Cancer Center An integral part of one of the world
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1969 W Ogden Ave
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Piedmont Fayette Hospital Piedmont Fayette Hospital, a 172-bed community hospital, is among the most highly-ranked...
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