Radiation and Androgen Ablation for Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins45 enrolled

Overview

A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.

This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adenocarcinoma of the Prostate

Interventions

Radiation TherapyRADIATION

7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)

Androgen Deprivation Therapy (ADT)DRUG

Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed, locally confined adenocarcinoma of the prostate * Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7). * The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer. * Signed study-specific consent form prior to registration Exclusion Criteria: * Stage T3-4 disease. * Gleason 8 or higher score. * PSA \> 20 ng/ml. * IPSS (International Prostate Symptom Score) \> 15 * Clinical or Pathological Lymph node involvement (N1). * Evidence of distant metastases (M1). * Radical surgery for carcinoma of the prostate. * Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer. * Previous pelvic radiation therapy. * Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years. * History of inflammatory bowel disease. * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. * Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11 * Liver function tests (LFTs) greater than twice the upper limit of normal.

Locations (3)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Suburban Hospital

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).

To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.

Time frame: From consent up to 5 years post treatment completion

Secondary Outcomes

Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events

Incidence of grade 3 or greater GU (genitourinary) and GI (gastrointestinal) toxicity with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently.

Time frame: Consent to up to 5 years of follow-up or biochemical failure.

Overall Survival Rate

Assess clinical control rate by measuring the Overall Survival (OS) which is defined as the percentage of participants who completed the study that lived from time of treatment until death from any cause.

Time frame: Start of treatment up to 5 years

Number of Patients Who Completed Blood Collection of Whole Blood for Future Research

Biomarker studies. Number of patients who completed blood collection of whole blood for future research.

Time frame: Up to 2 years post treatment

Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).

The International Prostate Symptom Score (IPSS) is a useful subjective assessment tool for Benign prostatic hyperplasia (BPH) patients; it is a modification of the American Urological Association (AUA) Symptom Index. The questionnaire assesses degree of Lower Urinary Tract Symptoms (LUTS) and quality of life. Patients can fill out the IPSS form before examinations, but minimal interference from health care providers must be ensured. Total score range 0-35; A score of 7 or less is mildly symptomatic, 8 to 19 is moderately symptomatic, and 20 to 35 is severely symptomatic.

Data from ClinicalTrials.gov

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