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Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation


Phase 2
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation


OBJECTIVES:

- Determine the feasibility and patient tolerance of interstitial brachytherapy combined
with androgen-deprivation therapy for patients with locally recurrent prostate cancer
after prior external-beam irradiation.

- Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation
therapy in these patients.

- Determine the tumor response to interstitial brachytherapy combined with
androgen-deprivation therapy in these patients.

OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly
for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of
leuprolide acetate administration. Patients then undergo interstitial brachytherapy
implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide
acetate every 3 months for an additional 6 months.

Quality of life is assessed at baseline and at every treatment and follow-up visit.

After completion of study therapy, patients are followed every 3 months for 2 years, every
to 4-6 months for 3 years, and then annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Biopsy-proven adenocarcinoma of the prostate

- Locally recurrent disease, defined by digital rectal examination and/or rising
prostate-specific antigen (PSA)

- No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination,
bone scan, or CT scan of the pelvis

- Clinical stage T1c-T3a disease at the time of recurrence

- PSA < 10 ng/mL

- Prostate volume by transrectal ultrasonography < 60 cc

- Received prior external beam radiotherapy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- WBC ≥ 3,000/μL

- Platelet count ≥ 90,000/μL

- Hemoglobin ≥ 10 g/dL

- Alkaline phosphatase < 2 times normal

- AST < 2 times normal

- Normal prothrombin time and partial thromboplastin time

- No significant obstructive urinary symptoms (AUA score ≤ 16)

- No contraindication for general anesthesia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior transurethral resection of the prostate

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Feasibility

Safety Issue:

No

Principal Investigator

William W. Wong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

07-00

NCT ID:

NCT00684905

Start Date:

April 2000

Completion Date:

October 2005

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404