Titre officiel
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
Sommaire:
Cet essai vise à comparer deux traitements semblables offerts aux patients ayant reçu un diagnostic de cancer de la prostate. Un premier groupe de patients recevra le traitement standard, lequel consiste en une hormonothérapie qui inhibe la production de l’hormone masculine, la testostérone, par les testicules et une radiothérapie externe pelvienne suivie d’une radiothérapie externe conformationnelle à fortes doses avec surimpression, et un autre groupe recevra le traitement expérimental, lequel consiste en une hormonothérapie et une radiothérapie externe pelvienne suivie d’une curiethérapie de surimpression (implantation de sources ou de « grains » d’iode radioactif dans la prostate). Cet essai vise à vérifier l’hypothèse selon laquelle un taux de survie actuarielle sans récidive biochimique du cancer de la prostate à 5 ans sera noté chez un plus grand nombre de patients après l’administration du traitement expérimental. L’échec biochimique est confirmé lorsque le taux d’antigène prostatique spécifique mesuré après le traitement est supérieur de plus de 2 ng/mL au taux le plus faible précédemment enregistré.
Description de l'essai
Primary Outcome:
- 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.
Secondary Outcome:
- This trial is also intended to determine 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.
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.
Voir cet essai sur ClinicalTrials.gov
