Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Androgens

Leuprolide

Goserelin

Flutamide

Antineoplastic Agents, Hormonal

Androgen Antagonists

Hormones

Hormone Antagonists

External beam radiation therapy + 6 months total androgen ablation

Flutamide (Eulexin) and Lupron or Zoladex

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

External Beam Radiotherapy

Anthony V D'Amico, M.D. Ph.D.

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.

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.

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

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

Brigham and Women's Hospital

Saint Anne's Hospital

Beth Israel Deaconess Medical Center

Metro West Medical Center

Dana-Farber Cancer Institute

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.

A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.

Prostate Biopsy, Focal Brachytherapy , Assessment of QOL

Michael Zelefsky, MD

The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.

Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

Phase II Study Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy Early Stage, Low Volume in Prostate Cancer

focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. "All negative" means no prostate cancer;

Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ

Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer	NCT00116220	Prostate Cancer	Flutamide (Eule... External Beam R...	41 Years -	Dana-Farber Cancer Institute
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer	NCT01354951	Prostate Cancer	Prostate Biopsy...	21 Years -	Memorial Sloan Kettering Cancer Center

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