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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604526
• Other study ID #: 06-122
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2008
• Last updated: January 4, 2016
• Start date: September 2006
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess biochemical or PSA relapse free survival.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center