Skip to main content
OpenTrials
Completed

NCT Number: NCT00604526

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: conclusion of study

Secondary outcomes

  1. To assess biochemical or PSA relapse free survival.

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2008
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.