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

Schiffler Cancer Center

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: External beam radiation; Drug: Lupron; Drug: Casodex

Study type: Interventional

Funder types: Other

Identifiers

NCT00243646

05-8-4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 6 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

6 participants in 2 patient groups

no hormones

Active Comparator group

Description:

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

Treatment:

Radiation: External beam radiation

9 months of hormone therapy

Active Comparator group

Description:

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

Treatment:

Drug: Casodex

Radiation: External beam radiation

Drug: Lupron