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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00243646

Enrollment

Registered

2005-10-24

Start date

2004-08-31

Completion date

2009-07-31

Last updated

2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Radiation therapy, Brachytherapy, Prostatic neoplasm

Brief summary

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.

Detailed description

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).

Interventions

RADIATIONExternal beam radiation

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

DRUGLupron

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).

DRUGCasodex

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
PSA 3 and 6 months following implantation then every 6 months.	3 and 6 months following implantation then every 6 months	PSA 3 and 6 months following implantation then every 6 months.
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.	3 and 6 months	Serum testosterone levels at 3 and 6 months in hormonally manipulated patients
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.	as needed	Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.

Secondary

Measure	Time frame	Description
EPIC on 6 and 12 months and then annually.	6 and 12 months and then annually.	EPIC on 6 and 12 months and then annually.
Hormonally manipulated patients will obtain a DEXA scan.	as needed	Hormonally manipulated patients will obtain a DEXA scan.
For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.	every 3 months is recommended.	For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026