Trial | NCT00243646  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    6
Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.
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).
Study Started
Aug 31
2004
Primary Completion
Jul 31
2009
Study Completion
Jul 31
2009
Last Update
Apr 14
2016
Estimate

Radiation External beam radiation

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant

Drug Lupron

9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).

Drug Casodex

9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).

no hormones Active Comparator

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones

9 months of hormone therapy Active Comparator

All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy

Criteria 

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.
No Results Posted