Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy

Prostate Cancer Clinical Trial

Official title: A Randomized Phase III Study Comparing Androgen Suppression and Elective Pelvic Nodal Irradiation Followed by High Dose 3-D Conformal Boost Versus Androgen Suppression and Elective Pelvic Nodal Irradiation Followed by 125-Iodine Brachytherapy Implant Boost for Patients With Intermediate and High Risk Localized Prostate Cancer

Status Active, not recruiting

Clinical Trial Summary

The purpose of this trial is to compare two similar treatments for patients diagnosed with prostate cancer. The two treatment arms being compared are: (Standard Arm) hormone therapy, which will prevent the production of the male hormone, testosterone, by the testicles, and pelvic external beam radiation therapy (EBRT) followed by a high-dose, conformal EBRT boost versus (Investigational Arm) hormone therapy and pelvic EBRT followed by a brachytherapy boost (implantation of radioactive iodine sources or "seeds" into the prostate).

The hypothesis of this trial is that more patients may experience 5 year actuarial freedom from biochemical recurrence of their prostate cancer following treatment with the investigational arm. Biochemical failure is declared on the date when the post treatment prostate specific antigen (PSA) is > 2 ng/mL above the lowest level previously recorded.

Clinical Trial Description

Patients will be randomly assigned with equal probability to one or two treatment arms, Arm 1 or Arm 2, where the interventions associated with these Arms are as follows:

Arm 1:

Neoadjuvant, concurrent and adjuvant androgen suppression, elective pelvic nodal irradiation (EPNI), high dose conformal EBRT boost to the prostate, and appropriate secondary interventions at failure.

Arm 2:

Neoadjuvant, concurrent and adjuvant androgen suppression, elective pelvic nodal irradiation (EPNI), permanent 125-Iodine brachytherapy boost to the prostate, and appropriate secondary interventions at failure.

If a patient is assigned to Arm 1, the radiation oncologist will initiate androgen suppression and monitor clinical and biochemical response. After an 8-month duration of neoadjuvant androgen suppression, the patient will undergo a course of elective pelvic nodal irradiation (EPNI) to a volume encompassing the prostate gland, seminal vesicles and regional lymph nodes. The pelvic irradiation will be followed by a dose-escalated 3-D conformal EBRT boost to the prostate with appropriate margins. The total radiation dose to the regional lymphatics is 46 Gy and prostate dose is 78 Gy at the ICRU reference point with a minimum dose to the PTV of > 74 Gy. Androgen suppression is maintained throughout radiation therapy and following the completion of radiation therapy until the patient has received a total duration of androgen suppression of 12 months including the neoadjuvant phase.

If the patient is assigned to Arm 2, the radiation oncologist will initiate androgen suppression and monitor clinical and biochemical response. After an 8-month duration of neoadjuvant androgen suppression, the patient will undergo a course of elective pelvic nodal irradiation (EPNI) to a volume encompassing the prostate gland, seminal vesicles and regional lymph nodes. The total radiation dose to the regional lymphatics is 46 Gy. Two weeks following the completion of the pelvic irradiation, the patient will undergo a permanent 125-Iodine brachytherapy prostate implant at the facilities of the participating institution by a team of healthcare professionals lead by a Radiation Oncologist with experience in prostate brachytherapy. To be eligible to participate, the institution must have done at least 25 cases of prostate brachytherapy with stranded sources. The minimal peripheral dose (MPD) to the prostate gland from the implant will be 115 Gy. A modified peripheral loading technique will be used in an effort to maintain the periurethral dose to < 150% of the MPD. Androgen suppression is maintained throughout radiation therapy until the patient has received a total duration of androgen suppression of 12 months including the neoadjuvant phase.

All patients randomized are part of the analysis. The patient remains on study whether or not protocol treatment defined for the assigned arm is completed. The end of the primary intervention is defined as 18 months following the start of neoadjuvant androgen suppression in both arms.

Secondary Objectives:

Overall survival, metastasis-free survival, pathological local control, incidence of acute and late side effects and complications associated with the treatment interventions, effect of the planned interventions on QOL and rate of testosterone recovery. ;

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00175396
• Study type: Interventional
• Source: University of British Columbia
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 2004
• Completion date: June 2014