Clinical trial NCT00604526: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: recurrent
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: conclusion of study
Secondary outcomes:
measure: To assess biochemical or PSA relapse free survival.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yoshiya Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References: