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A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity, Sexual Dysfunction

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Trial Information

A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer


OBJECTIVES:

Primary

- To demonstrate that 1-year health-related quality of life (HRQOL) for at least one
hypofractionated arm is not significantly lower than baseline as measured by the Bowel
and Urinary domains of the Expanded Prostate Cancer Index Composite (EPIC) instrument.

Secondary

- To estimate the degree of change in HRQOL in each arm for the Sexual and Hormonal EPIC
domains and the Utilization of Sexual Medications/Devices from baseline to 1 year, 2
years, and 5 years.

- To estimate the degree of change in global HRQOL in each arm as measured by the Euro
Quality of Life, 5 dimensions (EQ-5D) from baseline to 1 year, 2 years, and 5 years.

- To estimate the rate of acute and late gastrointestinal (GI) and genitourinary (GU)
toxicity for each arm at 1, 2, and 5 years.

- To estimate prostate-specific antigen (PSA) failure in each arm at 1, 2, and 5 years.

- To estimate disease-free survival (DFS) in each arm at 1, 2, and 5 years.

- To estimate Quality Adjusted Life Years for each arm at 1, 2, and 5 years using the
EQ-5D and DFS.

- To identify genetic markers associated with normal tissue toxicities resulting from
radiotherapy.

- To collect tumor tissue for biomarker studies.

- To estimate EPIC bowel and urinary HRQOL as continuous variables.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment
techniques/machine (all linear accelerator-based treatment [excluding cyberknife] vs
cyberknife vs protons). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo hypofractionated radiotherapy using intensity-modulated
radiation therapy (IMRT), cyberknife, or protons twice a week for approximately 2½
weeks (36.25 Gy total).

- Arm II: Patients undergo hypofractionated radiotherapy using IMRT, cyberknife, or
protons once a day, 5 days a week, for approximately 2½ weeks (51.6 Gy total).

Patients may undergo blood and tumor tissue collection for correlative studies.

Patients may also complete the Utilization of Sexual Medications/Devices, the European
Questionnaire-5D, and the Bowel and Urinary domains of the Expanded Prostate Cancer Index
Composite (EPIC) questionnaires at baseline and at 1, 2, and 5 years after completion of
radiation therapy.

After completion of study therapy, patients are followed-up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days
of randomization

- History/physical examination with digital rectal examination of the prostate
within 60 days prior to registration

- Histological evaluation of prostate biopsy with assignment of a Gleason score to
the biopsy material; Gleason scores 2-6 within 180 days of randomization

- Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization

- Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration;

- PSA should not be obtained within 10 days after prostate biopsy

- No evidence of distant metastases

- No regional lymph node involvement

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Willingness and ability to complete the Expanded Prostate Cancer Index Composite
(EPIC) questionnaire

- No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or
lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of
5 years (for example, carcinoma of the oral cavity is permissible; however, patients
with prior history of bladder cancer are not allowed)

- No 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

- Laboratory tests for liver function and coagulation parameters are not
required for entry into this protocol

- Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease
Control (CDC) definition

- HIV testing is not required for entry into this protocol

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

PRIOR CONCURRENT THERAPY:

- No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused
ultrasonography (HIFU) 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., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix),
anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol
(DES)), or surgical castration (orchiectomy)

- No finasteride within 30 days prior to registration

- Prostate-specific antigen (PSA) should not be obtained prior to 30 days after
stopping finasteride

- No dutasteride within 90 days prior to registration

- PSA should not be obtained prior to 90 days after stopping dutasteride

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- Patients on Coumadin or other blood-thinning agents are eligible for this study

- No concurrent 3D-conformal radiation therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients with change from baseline to the 1-year EPIC bowel-domain score that exceeds 5 points

Outcome Time Frame:

Pre-treatment to 1 year from the end of protocol treatment

Safety Issue:

No

Principal Investigator

Himu R. Lukka, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Margaret and Charles Juravinski Cancer Centre

Authority:

United States: Federal Government

Study ID:

RTOG 0938

NCT ID:

NCT01434290

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Radiation Toxicity
  • Sexual Dysfunction
  • radiation toxicity
  • sexual dysfunction
  • psychosocial effects of cancer and its treatment
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms
  • Sexual Dysfunctions, Psychological
  • Radiation Injuries

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Boston University Cancer Research CenterBoston, Massachusetts  02118
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
Emory Crawford Long HospitalAtlanta, Georgia  30308
Kaiser Permanente - Division of Research - OaklandOakland, California  94611
Rohnert Park Cancer CenterRohnert Park, California  94928
Arizona Center for Cancer Care - PeoriaPeoria, Arizona  85381
Urology Center of ColoradoDenver, Colorado  80211
Fox Chase Cancer Center BuckinghamFurlong, Pennsylvania  18925
Academic Urology Prostate CenterKing of Prussia, Pennsylvania  19406
Rothman Specialty HospitalBensalem, Pennsylvania  19020
Kaiser Permanente Santa Clara Medical CenterSanta Clara, California  95051