NCT00116220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Sep 1995

Longer than P75 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2005

Completed
9.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 6, 2022

Status Verified

December 1, 2021

Enrollment Period

5.6 years

First QC Date

June 27, 2005

Last Update Submit

December 16, 2021

Conditions

Prostate Cancer

Keywords

Prostate CancerTotal Androgen Suppressionendorectal coil MRIExternal Beam Radiation TherapyProstate Cancer- High Risk, clinically Organ-Confined

Outcome Measures

Primary Outcomes (1)

  • 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.

    Years

Secondary Outcomes (1)

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

    Years

Study Arms (2)

Treatment 1

ACTIVE COMPARATOR

External beam radiation therapy + 6 months total androgen ablation

Drug: Flutamide (Eulexin) and Lupron or ZoladexRadiation: External Beam Radiotherapy

Treatment 2

ACTIVE COMPARATOR

External beam radiation therapy

Radiation: External Beam Radiotherapy

Interventions

Flutamide (Eulexin) and Lupron or ZoladexDRUG

Androgen suppression therapy

Treatment 1
External Beam RadiotherapyRADIATION

Once a day, 4-5 days per week for approximately 2 months

Treatment 1Treatment 2

Eligibility Criteria

Age41 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior history of malignancy
  • Prior hormonal therapy or chemotherapy
  • Prior pelvic radiation therapy
  • Unable to tolerate lying still 5-10 minutes/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (16)

  • 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.

    PMID: 27186728BACKGROUND

  • 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.

    PMID: 26393854BACKGROUND

  • 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.

    PMID: 15315996RESULT

  • 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.

    PMID: 19957321RESULT

  • 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.

    PMID: 19864082RESULT

  • 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.

    PMID: 19858385RESULT

  • 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.

    PMID: 19395186RESULT

  • 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.

    PMID: 19395184RESULT

  • 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.

    PMID: 22498212RESULT

  • 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.

    PMID: 24693436RESULT

  • 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.

    PMID: 24864213RESULT

  • 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.

    PMID: 33999161DERIVED

  • 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.

    PMID: 28097317DERIVED

  • 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.

    PMID: 27601545DERIVED

  • 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.

    PMID: 23798006DERIVED

  • 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.

    PMID: 18212313DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

FlutamideLeuprolideGoserelin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Anthony V D'Amico, M.D. Ph.D.

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2005

First Posted

June 28, 2005

Study Start

September 1, 1995

Primary Completion

April 1, 2001

Study Completion

February 1, 2015

Last Updated

January 6, 2022

Record last verified: 2021-12

Locations

US(1)