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A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy


OBJECTIVES:

Primary

- Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU)
adverse events in patients with locally recurrent adenocarcinoma of the prostate
previously treated with external-beam radiotherapy who are currently receiving
transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.

Secondary

- Determine the acute treatment-related GI and GU adverse events in patients treated with
this regimen.

- Determine the overall survival of patients treated with this regimen.

- Determine the disease-free survival of patients treated with this regimen.

- Determine the disease-specific survival of patients treated with this regimen.

- Determine clinical patterns of tumor recurrence (time to local tumor progression or
distant failure) in patients treated with this regimen.

- Determine the time to biochemical failure in patients treated with this regimen.

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

OUTLINE: This is a prospective, multicenter study.

Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103
brachytherapy.

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

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate meeting the following
criteria:

- Stage I-II disease (T1-T2c) at initial diagnosis (prior to external-beam
radiotherapy), meeting one of the following criteria:

- Gleason score 7 and prostate-specific antigen (PSA) ≤ 10 ng/mL

- Gleason score 2-7 and PSA ≤ 20 ng/mL

- Locally recurrent disease > 30 months after completion of prior external-beam
radiotherapy

- Has undergone prostate biopsy within the past 180 days

- Prostate volume ≤ 45 mL as measured by transrectal ultrasound or pubic arch
interference ruled out

- American Urological Association (AUA) Symptom Index Score < 15

- The use of alpha blockers is permitted when evaluating lower urinary tract
symptoms (i.e., the AUA score with the patient on alpha blockers is allowed)

- Baseline serum PSA < 10 ng/mL within 8 weeks prior to study entry OR within 8 weeks
prior to initiation of hormonal therapy OR more than 10 days prior to prostate biopsy

- No histologic or radiologic evidence of tumor involvement of regional lymph nodes
(N1)

- Negative lymph nodes by imaging (pelvic with or without abdominal CT scan or
MRI), or by nodal dissection (laparoscopy or laparotomy) within the past 8 weeks

- No clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis
(i.e., prior to external-beam radiotherapy) or at the time of local recurrence (i.e.,
prior to study entry)

- No evidence of bone metastases (M0) on bone scan within the past 8 weeks or other
metastatic disease (M1)

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Must be suitable for spinal or general anesthesia

- No prior invasive (except nonmelanoma skin cancer) or hematological (e.g., acute
leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for ≥ 3 years

- Prior low-grade lymphoma or chronic lymphocytic leukemia allowed

- No persistent late gastrointestinal or genitourinary toxicity ≥ grade 2

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or decompensated congestive heart failure

- Myocardial infarction within the past 6 months

- Bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Acquired immune deficiency syndrome (AIDS)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior transurethral resection of the prostate

- No prior radionuclide (permanent or temporary implantation) prostate brachytherapy

- No prior prostatectomy or prostatic cryosurgery

- No prior high-intensity focused ultrasound

- No prior bilateral orchiectomy

- No prior chemotherapy for prostate cancer

- At least 2 months but ≤ 6 months since initiation of prior luteinizing
hormone-releasing hormone agonist

- Any combination of prior neoadjuvant, concurrent, or adjuvant androgen suppression
therapy at the time of initial diagnosis and external-beam radiotherapy allowed
provided the total duration of treatment was ≤ 8 months

- If the total duration of treatment was > 8 months, evidence of a normal serum
testosterone must be documented

- No prior external-beam radiotherapy to the prostate such that the minimum dose to the
prostate exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8
Gy fractions)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events

Safety Issue:

Yes

Principal Investigator

Juanita M. Crook, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Unspecified

Study ID:

CDR0000533887

NCT ID:

NCT00450411

Start Date:

May 2007

Completion Date:

Related Keywords:

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

Name

Location

Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
California Cancer Center - Woodward Park OfficeFresno, California  93720
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Flower Hospital Cancer CenterSylvania, Ohio  43560
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. PetersSaint Peters, Missouri  63376
Robinson Radiation OncologyRavenna, Ohio  44266