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

NCT00604526 | Completed Phase 1

• 1 other identifier: 06-122
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

recurrent

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of study

Secondary Outcomes (1)

• To assess biochemical or PSA relapse free survival.

  conclusion of study

Study Arms (1)

1

EXPERIMENTAL

Questionnaires, Iridium 192 radioactive seeds

Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds

Interventions

High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds RADIATION

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.

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoshiya Yamada, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 30, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)