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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary end point of this trial is 5 year actuarial freedom from biochemical recurrence (5 year bNED) using the Houston definition of biochemical failure.
5 years
No
William J Morris, MD
Principal Investigator
University of British Columbia
Canada: Health Canada
R04-0050
NCT00175396
May 2004
December 2013
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