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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Questionnaires, Iridium 192 radioactive seeds | Radiation: High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess biochemical or PSA relapse free survival. |  | conclusion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent