Radiation Therapy in Treating Patients With Prostate Cancer

NCT01434290 | Completed Phase 2 Results DMC

• 3 other identifiers: RTOG 0938CDR0000703580NCI-2011-03629
• Study Type: interventional
• Target: 255
• Locations: 2 countries
• Sites: 37

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in treating patients with prostate cancer.

Conditions

Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Radiation Toxicity; Sexual Dysfunction

Keywords

radiation toxicity; sexual dysfunction; psychosocial effects of cancer and its treatment; adenocarcinoma of the prostate; stage I prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points

  The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year \> 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.

  Baseline and one year from the end of protocol treatment

• The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points

  The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year \> 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.

  Baseline and one year from the end of protocol treatment

Secondary Outcomes (10)

• Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm

  Start of protocol treatment to one year from the end of protocol treatment

• Rate of PSA Failure

  Registration to five years

• Rate of Disease-free Survival (DFS)

  Registration to 5 years

• Mean Quality Adjusted Life Years at 5 Years

  Registration to 5 years from the end of protocol treatment

• Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year

  Baseline and one year from the end of protocol treatment

Study Arms (2)

5 Fractions

EXPERIMENTAL

36.25 Gy IMRT in 5 fractions over two and a half weeks

Radiation: 36.25 Gy IMRT

12 Fractions

EXPERIMENTAL

51.6 Gy IMRT in 12 fractions over two and a half weeks

Radiation: 51.6 Gy IMRT

Interventions

36.25 Gy IMRT RADIATION

36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.

5 Fractions

51.6 Gy IMRT RADIATION

51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.

12 Fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (37)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Arizona Center for Cancer Care - Peoria

Peoria, Arizona, 85381, United States

Location

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Kaiser Permanente - Division of Research - Oakland

Oakland, California, 94611, United States

Location

Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States

Location

Kaiser Permanente Medical Center - Roseville

Roseville, California, 95678, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, 94080, United States

Location

Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Rothman Specialty Hospital

Bensalem, Pennsylvania, 19020, United States

Location

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, 18925, United States

Location

Academic Urology Prostate Center

King of Prussia, Pennsylvania, 19406, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Columbia-Saint Mary's Cancer Care Center

Milwaukee, Wisconsin, 53211, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Grand River Regional Cancer Centre at Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Himu R. Lukka, MD

  Margaret and Charles Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 14, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: May 20, 2022
• Last Updated: June 9, 2022
• Results First Posted: November 17, 2017

Record last verified: 2022-05

Locations

CA (5); US (32)