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

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Total Androgen Suppression, endorectal coil MRI, External Beam Radiation Therapy, Prostate Cancer- High Risk, clinically Organ-Confined

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.

Martin T. King, Ming‐Hui Chen, Laurence Collette, Anouk Neven, M. Bolla et al. (6 authors)

JAMA Network Open2021-05-176 citations

10.1001/jamanetworkopen.2021.11092

Early versus delayed initiation of salvage androgen deprivation therapy and the risk of prostate cancer-specific mortality.

Brandon A. Mahal, Ming‐Hui Chen, Andrew A. Renshaw, Philip W. Kantoff, Anthony V. D’Amico

Journal of Clinical Oncology2018-02-201 citations

10.1200/jco.2018.36.6_suppl.189

A comparison of surrogate endpoints for all cause mortality in men with localized unfavorable-risk prostate cancer.

Trevor J. Royce, Ming‐Hui Chen, Jing Wu, Marian Loffredo, Andrew A. Renshaw et al. (7 authors)

Journal of Clinical Oncology2017-02-20

10.1200/jco.2017.35.6_suppl.21

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

Trevor J. Royce, Ming‐Hui Chen, Jing Wu, Marian Loffredo, Andrew A. Renshaw et al. (7 authors)

JAMA Oncology2017-01-1847 citations

10.1001/jamaoncol.2016.5983

Duration of the anti-androgen in men undergoing six months of an LHRH agonist and radiation therapy for unfavorable-risk prostate cancer and the risk of death.

Nina N. Sanford, Ming‐Hui Chen, Marian Loffredo, Andrew A. Renshaw, Philip W. Kantoff et al. (6 authors)

Journal of Clinical Oncology2016-05-20

10.1200/jco.2016.34.15_suppl.5070

Obesity and the odds of weight gain following androgen deprivation therapy for prostate cancer: Toward a risk adapted approach for ADT use.

Lior Z. Braunstein, Ming‐Hui Chen, Marian Loffredo, Philip W. Kantoff, Anthony V. D’Amico

Journal of Clinical Oncology2014-05-201 citations

10.1200/jco.2014.32.15_suppl.5045

Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial.

D'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW.

2008-01-01489 citations

10.1001/jama.299.3.289

Interventions

DRUGFlutamide (Eulexin) and Lupron or Zoladex

Androgen suppression therapy

RADIATIONExternal Beam Radiotherapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

41 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Evaluate the quality of life of patients receiving total androgen suppression and radiation therapy	Years

Countries

United States

Outcome results

None listed