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Radiation and Androgen Ablation for Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Radiation Therapy
Androgen Deprivation Therapy (ADT)
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sibley Memorial Hospital
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Suburban Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation with Androgen Deprivation Therapy (ADT)

Arm 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, 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Various Control Rate Assessments
Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.
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.
Biomarker Studies
Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.
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.

Full Information

First Posted
January 20, 2012
Last Updated
May 30, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT01517451
Brief Title
Radiation and Androgen Ablation for Prostate Cancer
Official Title
Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 22, 2013 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation with Androgen Deprivation Therapy (ADT)
Arm Type
Experimental
Arm 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, 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.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
Intervention Type
Drug
Intervention Name(s)
Androgen Deprivation Therapy (ADT)
Intervention Description
Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
Primary Outcome Measure Information:
Title
Biochemical failure free-rate
Description
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.
Time Frame
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 Measure Information:
Title
Various Control Rate Assessments
Description
Assess biochemical, clinical, and pathologic control rates associated with the combined hypofractionated dose regimen and ADT.
Time Frame
1 year
Title
Dose Volume/ Imaging Data Assessments
Description
Collect dose/volume and imaging data to allow normal tissue complication probability modeling and targeting assessment for patients treated with hypofractionated radiation therapy.
Time Frame
1 year
Title
Biomarker Studies
Description
Collect whole blood to perform correlative studies for serum cytokine profiling and future biomarker studies.
Time Frame
1 year
Title
Gastrointestinal (GI) and Genitourinary (GU toxicity) assessment
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phuoc Tran, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Radiation and Androgen Ablation for Prostate Cancer

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