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Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial


Phase 3
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial


In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately
30,000 will subsequently die of metastatic disease. Although the vast majority of men will
be diagnosed with clinically localized and potentially curable disease, the selection of one
local modality over another remains a focus of significant controversy within the
uro-oncology community. However, patients with higher risk features are most often managed
with radiotherapeutic approaches to include androgen deprivation therapy.

Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and
permits dose escalation far exceeding other modalities. Following permanent prostate
brachytherapy with or without supplemental external beam radiation therapy, favorable
long-term biochemical outcomes have been reported for patients with low, intermediate and
high risk features with a morbidity profile that compares favorably with competing local
modalities (1,2).

Several prospective randomized trials have demonstrated that androgen deprivation therapy in
conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in
improvement in disease-free and overall survival in patients with locally advanced prostate
cancer (3,4).


Inclusion Criteria:



- High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score
greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).

- CT of the abdomen and pelvis and bone scan without evidence of metastases.

- An enzymatic prostatic acid phosphatase must be obtained prior to randomization.

- A serum testosterone must be obtained prior to initiation of androgen deprivation
therapy.

- No prior pelvic external beam radiation therapy for prostate cancer or other
malignancies.

- No prior androgen deprivation therapy.

- Minimum 5 year life expectancy.

- No other invasive cancer diagnosis other than non-melanoma skin cancer within the
last 5 years.

Exclusion Criteria:

- Exclusion criteria will be limited to patients who do not meet the above eligibility
criteria.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA 3 and 6 months following implantation then every 6 months.

Outcome Description:

PSA 3 and 6 months following implantation then every 6 months.

Outcome Time Frame:

3 and 6 months following implantation then every 6 months

Safety Issue:

No

Principal Investigator

Gregory S Merrick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Schiffler Cancer Center, Wheeling, WV

Authority:

United States: Institutional Review Board

Study ID:

05-8-4

NCT ID:

NCT00243646

Start Date:

August 2004

Completion Date:

July 2009

Related Keywords:

  • Prostate Cancer
  • Radiation therapy
  • Brachytherapy
  • Prostatic neoplasm
  • Prostatic Neoplasms

Name

Location

Schiffler Cancer CenterWheeling, West Virginia  26003
Groupe Health Cooperative, Veterans Adminstration Hospital and University of WashingtonSeattle, Washington  98108
Seattle Prostate InstituteSeattle, Washington  98104