Radiation and Androgen Ablation for Prostate Cancer

Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate

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

Study Overview

• Status: Active, not recruiting
• Conditions: Adenocarcinoma of the Prostate
• Intervention / Treatment: Radiation: Radiation Therapy; Drug: Androgen Deprivation Therapy (ADT)

Detailed Description

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
• Enrollment (Actual): 105
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiation with Androgen Deprivation Therapy (ADT); 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, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.

Radiation: Radiation Therapy; 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions); Drug: Androgen Deprivation Therapy (ADT); Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical failure free-rate	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.	1, 2, 3, 6 12, 18. 24, 30, 36 mont, 4 year and 5 year follow-up points after treatment has been completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Various Control Rate Assessments	Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.	1 year
Dose Volume/ Imaging Data Assessments	Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.	1 year
Biomarker Studies	Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.	1 year
Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment	1) Assess the 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.	1 year

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Phuoc Tran, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2013
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimated): January 25, 2012

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Adenocarcinoma; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: J11157; NA_00067963 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED