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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


N/A
18 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Yoshiya Yamada, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-122

NCT ID:

NCT00604526

Start Date:

September 2006

Completion Date:

September 2013

Related Keywords:

  • Prostate Cancer
  • recurrent
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021