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A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy


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

Thank you

Trial Information

A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy


OBJECTIVES:

- Determine the nature, intensity, and time course of health-related quality of life
changes in patients with locally recurrent prostate adenocarcinoma treated with
androgen suppression and transperineal ultrasound-guided brachytherapy after external
beam radiotherapy.

- Determine the morbidity of patients treated with this regimen.

- Determine the overall survival, disease-free survival, and disease-specific survival of
patients treated with this regimen.

- Determine the clinical patterns of tumor recurrence (i.e., time to local tumor
progression or distant failure) and time to biochemical failure of patients treated
with this regimen.

- Determine the post-brachytherapy dosimetric coverage of patients treated with this
regimen.

OUTLINE: This is a multicenter study.

Patients receive androgen suppression comprising goserelin subcutaneously (as either 4
one-month depot injections or 1 one-month depot injection and 1 three-month depot injection)
OR leuprolide intramuscularly (as 4 one-month depot injections or 1 one-month depot
injection and 1 three-month depot injection or 1 four-month depot injection) AND oral
flutamide 3 times daily for 112 days OR oral bicalutamide once daily for 112 days.

Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled
to 2 different cohorts of brachytherapy.

- Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate
brachytherapy with iodine I 125 or palladium Pd 103.

- Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if
tolerance is acceptable, additional patients undergo higher-dose transperineal
interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103.

Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3
months for 1 year, and then every 6 months for 2 years.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 83-166 patients (83 per cohort) will be accrued for this study
within 1.5-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed locally recurrent or persistent prostate adenocarcinoma

- Locally recurrent disease

- Prostate-specific antigen (PSA) no greater than 10 ng/mL

- N0 and M0 (at time of initial diagnosis and at time of local recurrence)

- Lymph nodes must be negative or will be negative after nodal sampling or
dissection

- More than 18 months after completion of prior external beam radiotherapy

- Must have had 1 of the following disease characteristics prior to external beam
radiotherapy:

- T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL

- T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL

- T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL

- Must have American Urological Association Symptom Index score no greater than 15

- Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL

- No pubic arch interference of more than 1/3 the prostatic volume determined by
transrectal ultrasound or pelvic CT scan

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1 OR

- ECOG 0-1

Life expectancy:

- At least 5 years

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No persistent late intestinal or bladder toxicity grade 2 or greater

- No other major medical or psychiatric illness that would preclude study

- No metallic hip prosthesis

- No other malignancy within the past 5 years except localized basal cell or squamous
cell skin cancer

- No other concurrent illness that would limit life expectancy

- Suitable for spinal or general anesthesia

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for prostate cancer

Endocrine therapy:

- At least 12 months since prior androgen suppression except goserelin or leuprolide
with flutamide or bicalutamide begun within the past 30 days

Radiotherapy:

- See Disease Characteristics

- No prior external beam radiotherapy doses exceeding 71 Gy to the prostate

- No prior radionuclide prostate brachytherapy

Surgery:

- No prior transurethral prostate resection

- No prior prostatectomy or prostatic cryosurgery

- No prior bilateral orchiectomy

Other:

- No concurrent participation in another medical research study for prostate cancer
treatment

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas M. Pisansky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069248

NCT ID:

NCT00032006

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • recurrent prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
Mayo ClinicJacksonville, Florida  32224