search
Back to results

High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds
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 recurrent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • KPS > than or equal to 80
  • Able to give informed consent
  • Able to complete toxicity scales and questionnaires
  • Histologically MSKCC confirmed diagnosis of recurrent prostate cancer.
  • Documented history of definitive radiotherapy to the prostate gland
  • IPSS of < than or equal to 15 at the time of evaluation
  • PSA < than or equal to 15 ng/ml
  • Organ confined disease

Exclusion Criteria:

  • Unable to tolerate general anesthesia
  • Abnormal complete blood count. Any of the following:
  • Platelet count less than 75,000/ml
  • Hb level less than 10 gm/dl
  • WBC less than 3.5/ml
  • Abnormal coagulation profile:
  • INR > 2.5
  • Abnormal Liver function tests (>1.5 x normal value)
  • Abnormal renal function tests (creatinine > 1.5)
  • Evidence of metastatic disease (bone scan, radiographs, MRI findings)
  • Prostate volume > 50 cc
  • Unable to meet treatment planning criteria
  • History of rectal surgery
  • External beam radiation dose to the prostate > 86.4 Gy if standard treatment planning dose constraints were met
  • History of inflammatory bowel disease
  • Expected survival < 1 year
  • Unable to undergo bone scan, CT or MRI evaluation
  • Unavailable for regular follow up

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Questionnaires, Iridium 192 radioactive seeds

Outcomes

Primary Outcome Measures

assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity.

Secondary Outcome Measures

To assess biochemical or PSA relapse free survival.

Full Information

First Posted
January 8, 2008
Last Updated
January 4, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00604526
Brief Title
High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Official Title
Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (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
High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Questionnaires, Iridium 192 radioactive seeds
Intervention Type
Radiation
Intervention Name(s)
High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds
Intervention Description
Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL *After 1 year, will follow up with doctor about every 6 months.
Primary Outcome Measure Information:
Title
assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity.
Time Frame
conclusion of study
Secondary Outcome Measure Information:
Title
To assess biochemical or PSA relapse free survival.
Time Frame
conclusion of study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: KPS > than or equal to 80 Able to give informed consent Able to complete toxicity scales and questionnaires Histologically MSKCC confirmed diagnosis of recurrent prostate cancer. Documented history of definitive radiotherapy to the prostate gland IPSS of < than or equal to 15 at the time of evaluation PSA < than or equal to 15 ng/ml Organ confined disease Exclusion Criteria: Unable to tolerate general anesthesia Abnormal complete blood count. Any of the following: Platelet count less than 75,000/ml Hb level less than 10 gm/dl WBC less than 3.5/ml Abnormal coagulation profile: INR > 2.5 Abnormal Liver function tests (>1.5 x normal value) Abnormal renal function tests (creatinine > 1.5) Evidence of metastatic disease (bone scan, radiographs, MRI findings) Prostate volume > 50 cc Unable to meet treatment planning criteria History of rectal surgery External beam radiation dose to the prostate > 86.4 Gy if standard treatment planning dose constraints were met History of inflammatory bowel disease Expected survival < 1 year Unable to undergo bone scan, CT or MRI evaluation Unavailable for regular follow up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiya Yamada, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy

We'll reach out to this number within 24 hrs