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Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Flutamide (Eulexin) and Lupron or Zoladex
External Beam Radiotherapy
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Total Androgen Suppression, endorectal coil MRI, External Beam Radiation Therapy, Prostate Cancer- High Risk, clinically Organ-Confined

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Biopsy proven prostate cancer Negative bone scan Lymph nodes by CT or MRI Adequate blood work Performance Status - ECOG 0-1 Life expectancy of at least 10 years >40 years of age Exclusion Criteria: Prior history of malignancy Prior hormonal therapy or chemotherapy Prior pelvic radiation therapy Unable to tolerate lying still 5-10 minutes/day

Sites / Locations

  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment 1

Treatment 2

Arm Description

External beam radiation therapy + 6 months total androgen ablation

External beam radiation therapy

Outcomes

Primary Outcome Measures

To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.

Secondary Outcome Measures

Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy

Full Information

First Posted
June 27, 2005
Last Updated
December 16, 2021
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Saint Anne's Hospital, Beth Israel Deaconess Medical Center, Metro West Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00116220
Brief Title
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
Official Title
A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Saint Anne's Hospital, Beth Israel Deaconess Medical Center, Metro West Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.
Detailed Description
This was a randomized study comparing external beam radiation therapy with total androgen ablation for 6 months with radiation therapy alone. Drugs were given 2 months prior, 2 months during, and 2 months after radiation therapy. Eulexin and Lupron or Zoladex was used in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Total Androgen Suppression, endorectal coil MRI, External Beam Radiation Therapy, Prostate Cancer- High Risk, clinically Organ-Confined

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Active Comparator
Arm Description
External beam radiation therapy + 6 months total androgen ablation
Arm Title
Treatment 2
Arm Type
Active Comparator
Arm Description
External beam radiation therapy
Intervention Type
Drug
Intervention Name(s)
Flutamide (Eulexin) and Lupron or Zoladex
Intervention Description
Androgen suppression therapy
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy
Intervention Description
Once a day, 4-5 days per week for approximately 2 months
Primary Outcome Measure Information:
Title
To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.
Time Frame
Years
Secondary Outcome Measure Information:
Title
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy
Time Frame
Years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy proven prostate cancer Negative bone scan Lymph nodes by CT or MRI Adequate blood work Performance Status - ECOG 0-1 Life expectancy of at least 10 years >40 years of age Exclusion Criteria: Prior history of malignancy Prior hormonal therapy or chemotherapy Prior pelvic radiation therapy Unable to tolerate lying still 5-10 minutes/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony V D'Amico, M.D. Ph.D.
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27186728
Citation
Taneja SS. Re: Long-Term Follow-up of a Randomized Trial of Radiation with or without Androgen Deprivation Therapy for Localized Prostate Cancer. J Urol. 2016 May;195(5):1471-1473. doi: 10.1016/j.juro.2016.02.022. Epub 2016 Feb 10. No abstract available.
Results Reference
background
PubMed Identifier
26393854
Citation
D'Amico AV, Chen MH, Renshaw A, Loffredo M, Kantoff PW. Long-term Follow-up of a Randomized Trial of Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer. JAMA. 2015 Sep 22-29;314(12):1291-3. doi: 10.1001/jama.2015.8577. No abstract available.
Results Reference
background
PubMed Identifier
15315996
Citation
D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821.
Results Reference
result
PubMed Identifier
19957321
Citation
Nguyen PL, Chen MH, Beard CJ, Suh WW, Choueiri TK, Efstathiou JA, Hoffman KE, Loffredo M, Kantoff PW, D'Amico AV. Comorbidity, body mass index, and age and the risk of nonprostate-cancer-specific mortality after a postradiation prostate-specific antigen recurrence. Cancer. 2010 Feb 1;116(3):610-5. doi: 10.1002/cncr.24818.
Results Reference
result
PubMed Identifier
19864082
Citation
Nguyen PL, Chen MH, Beard CJ, Suh WW, Renshaw AA, Loffredo M, McMahon E, Kantoff PW, D'Amico AV. Radiation with or without 6 months of androgen suppression therapy in intermediate- and high-risk clinically localized prostate cancer: a postrandomization analysis by risk group. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1046-52. doi: 10.1016/j.ijrobp.2009.06.038. Epub 2009 Oct 26.
Results Reference
result
PubMed Identifier
19858385
Citation
Wo JY, Chen MH, Nguyen PL, Renshaw AA, Loffredo MJ, Kantoff PW, D'Amico AV. Evaluating the combined effect of comorbidity and prostate-specific antigen kinetics on the risk of death in men after prostate-specific antigen recurrence. J Clin Oncol. 2009 Dec 10;27(35):6000-5. doi: 10.1200/JCO.2009.23.6067. Epub 2009 Oct 26.
Results Reference
result
PubMed Identifier
19395186
Citation
Nguyen PL, Chen MH, Renshaw AA, Loffredo M, Kantoff PW, D'Amico AV. Survival following radiation and androgen suppression therapy for prostate cancer in healthy older men: implications for screening recommendations. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):337-41. doi: 10.1016/j.ijrobp.2009.01.045. Epub 2009 Apr 22.
Results Reference
result
PubMed Identifier
19395184
Citation
D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Interval to testosterone recovery after hormonal therapy for prostate cancer and risk of death. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):10-5. doi: 10.1016/j.ijrobp.2008.10.082. Epub 2009 Apr 22.
Results Reference
result
PubMed Identifier
22498212
Citation
Tseng YD, Chen MH, Beard CJ, Martin NE, Orio PF, Loffredo M, Renshaw AA, Choueiri TK, Hu JC, Kantoff PW, D'Amico AV, Nguyen PL. Posttreatment prostate specific antigen nadir predicts prostate cancer specific and all cause mortality. J Urol. 2012 Jun;187(6):2068-73. doi: 10.1016/j.juro.2012.01.073. Epub 2012 Apr 11.
Results Reference
result
PubMed Identifier
24693436
Citation
Chandra RA, Chen MH, Zhang D, Loffredo M, D'Amico AV. Evidence suggesting that obesity prevention measures may improve prostate cancer outcomes using data from a prospective randomized trial. Prostate Cancer. 2014;2014:478983. doi: 10.1155/2014/478983. Epub 2014 Feb 13.
Results Reference
result
PubMed Identifier
24864213
Citation
Braunstein LZ, Chen MH, Loffredo M, Kantoff PW, D'Amico AV. Obesity and the Odds of Weight Gain following Androgen Deprivation Therapy for Prostate Cancer. Prostate Cancer. 2014;2014:230812. doi: 10.1155/2014/230812. Epub 2014 Apr 22.
Results Reference
result
PubMed Identifier
33999161
Citation
King MT, Chen MH, Collette L, Neven A, Bolla M, D'Amico AV. Association of Increased Prostate-Specific Antigen Levels After Treatment and Mortality in Men With Locally Advanced vs Localized Prostate Cancer: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 May 3;4(5):e2111092. doi: 10.1001/jamanetworkopen.2021.11092.
Results Reference
derived
PubMed Identifier
28097317
Citation
Royce TJ, Chen MH, Wu J, Loffredo M, Renshaw AA, Kantoff PW, D'Amico AV. Surrogate End Points for All-Cause Mortality in Men With Localized Unfavorable-Risk Prostate Cancer Treated With Radiation Therapy vs Radiation Therapy Plus Androgen Deprivation Therapy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):652-658. doi: 10.1001/jamaoncol.2016.5983.
Results Reference
derived
PubMed Identifier
27601545
Citation
Giacalone NJ, Wu J, Chen MH, Renshaw A, Loffredo M, Kantoff PW, D'Amico AV. Prostate-Specific Antigen Failure and Risk of Death Within Comorbidity Subgroups Among Men With Unfavorable-Risk Prostate Cancer Treated in a Randomized Trial. J Clin Oncol. 2016 Nov 1;34(31):3781-3786. doi: 10.1200/JCO.2016.68.4530. Erratum In: J Clin Oncol. 2018 Feb 10;36(5):521.
Results Reference
derived
PubMed Identifier
23798006
Citation
Kim MB, Chen MH, de Castro M, Loffredo M, Kantoff PW, D'Amico AV. Defining the optimal approach to the patient with postradiation prostate-specific antigen recurrence using outcome data from a prospective randomized trial. Cancer. 2013 Sep 15;119(18):3280-6. doi: 10.1002/cncr.28202. Epub 2013 Jun 24.
Results Reference
derived
PubMed Identifier
18212313
Citation
D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289.
Results Reference
derived

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Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer

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