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

Prostate Cancer Clinical Trial

Official title:

A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116220
• Other study ID #: 95-096
• Status: Completed
• Phase: Phase 3
• Start date: September 1995
• Est. completion date: February 2015

Study information

• Verified date: December 2021
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: February 2015
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 41 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Flutamide (Eulexin) and Lupron or Zoladex
Androgen suppression therapy

Radiation:
• External Beam Radiotherapy
Once a day, 4-5 days per week for approximately 2 months

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Metro West Medical Center, Saint Anne's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. Ep — View 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. — View 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 — View 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 — View 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 r — View 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 an — View 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 — View 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. — View 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 — View 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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy		Years