Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175396
Status:
UNKNOWN
Last Update Posted:
2014-03-17
First Post:
2005-09-11
Brief Title:
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation Therapy
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
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:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ngmL above the lowest level previously recorded
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 ngmL above the lowest level previously recorded
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H04-60050 | None | None | None |