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Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
external beam radiation therapy
brachytherapy
questionnaires
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Radiation Therapy, Brachytherapy, 14-163

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as:
  • Pathologically-proven diagnosis of prostate adenocarcinoma
  • PSA 10-20ng/mL or
  • Gleason =7 or
  • Clinical stage T2b/c
  • Clinical stage T2b/c Additionally, patients will be required to meet the following criteria
  • Age ≥18
  • KPS≥70
  • Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician.
  • International Prostate Symptom Score ≤15

Exclusion Criteria:

  • Prior prostate surgery (including TURP)
  • Prior history of chronic prostatitis or urethral stricture
  • Inflammatory bowel disease
  • Prior history of pelvic radiotherapy
  • Unable to give informed consent
  • Metastatic disease.

Sites / Locations

  • Memorial Sloan Kettering at Basking Ridge
  • Memorial Sloan Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering at Mercy Medical Center
  • Memorial Sloan Kettering Nassau (Follow Up Only)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiation therapy in combination with brachytherapy

Arm Description

Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate & seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, & treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) & every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal & sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy

Outcomes

Primary Outcome Measures

late urinary toxicity assessed by CTCAE v4.0
at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.

Secondary Outcome Measures

International Prostate Symptom Score (IPSS) to assess urinary functioning
IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning.

Full Information

First Posted
October 29, 2014
Last Updated
January 10, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02280356
Brief Title
Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Official Title
Ultra-hypofractionated, Image-guided, Intensity-modulated Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 28, 2014 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test the safety and side effects "of "ultra-hypofractionated" radiation therapy when used after brachytherapy (radiation implants). This treatment delivers a higher radiation dose with each treatment over a shorter period of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Radiation Therapy, Brachytherapy, 14-163

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
radiation therapy in combination with brachytherapy
Arm Type
Experimental
Arm Description
Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate & seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, & treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) & every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal & sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
Intervention Type
Radiation
Intervention Name(s)
external beam radiation therapy
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Other Intervention Name(s)
International Prostate Symptom Score, International Index of Erectile Function-6, EPIC urinary, bowel and sexual domain
Primary Outcome Measure Information:
Title
late urinary toxicity assessed by CTCAE v4.0
Description
at approximately 12 months of hypofractionated radiation therapy in combination with brachytherapy for the treatment of intermediate risk prostate cancer.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) to assess urinary functioning
Description
IPSS index is a seven item questionnaire designed to assess urinary functioning, specifically urinary frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency. Questions are rated on a six point Likert scale with higher scores indicating more difficulty in urinary functioning.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Intermediate risk prostate cancer patients will be eligible for this study. Intermediate risk grouping will be assessed per NCCN guidelines as: Pathologically-proven diagnosis of prostate adenocarcinoma PSA 10-20ng/mL or Gleason =7 or Clinical stage T2b/c Clinical stage T2b/c Additionally, patients will be required to meet the following criteria Age ≥18 KPS≥70 Prostate volume ≤ 60cc (cytoreductive androgen deprivation therapy prior to brachytherapy of ≤ 6 months duration will be allowed to achieve this goal). For patients with a prostate volume between 50-60ccs, hormone therapy will be at the discretion of the physician. International Prostate Symptom Score ≤15 Exclusion Criteria: Prior prostate surgery (including TURP) Prior history of chronic prostatitis or urethral stricture Inflammatory bowel disease Prior history of pelvic radiotherapy Unable to give informed consent Metastatic disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Kollmeier, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Follow Up Only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Radiation Therapy in Combination With Brachytherapy for Clinically Localized, Intermediate Risk Prostate Cancer

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