Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247312
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2005-10-28
Brief Title:
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer A Prospective Randomized Trial
Sponsor:
Schiffler Cancer Center
Organization:
Schiffler Cancer Center
Study Overview
Official Title:
Pd-103 Dose De-Escalation for Early Stage Prostate Cancer A Prospective Randomized Trial
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
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 study is to determine the most appropriate radiation implant dose for palladium-103 monotherapy Radiation dose is related to potential cure From previously published studies it appears that the prescribed radiation dose can be reduced by 14-20 without any difference in potential cure in this study the dose is being decreased 10 Although most patients tolerate brachytherapy well complications to appear to be related to radiation exposure to normal structures ie urethra rectum and proximal penis By reducing the prescribed dose it is conceivable that fewer patients will experience side effects and complications
Detailed Description:
In calendar year 2003 approximately 220 000 men will be diagnosed with prostate cancer and approximately 30000 will die The vast majority of men will be diagnosed with clinically organ-confined disease with potentially curative treatments including radical prostatectomy external beam radiation therapy and brachytherapy Within the uro-oncology community the selection of one modality over another remains controversial
Over the past decade transperineal ultrasound-guided permanent prostate brachytherapy using either Pd-130 or I-125 has been increasingly utilized as definitive management for early stage carcinoma of the prostate gland This resurgence of interest in prostate brachytherapy was the result of several technologic advances including the evolution of transrectal ultrasonography the development of a closed transperineal approach and the availability of sophisticated treatment planning computers These imaging and planning advances significantly improved the accuracy of seed placement In addition the advent of CT-based postoperative dosimetry in the early 1990s provided a unique opportunity to evaluate quality and proactively predict outcome and complications
Prostate brachytherapy represents the ultimate 3-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 122
Although there is no definitive evidence suggesting that either Pd-103 or I-125 is more efficacious than the other in terms of cure or side effectscomplications preliminary results of a prospective randomized trial suggests that Pd-103 may be more dose forgiving than I-125 3 Long-term results demonstrate cancer eradication is highly correlated with delivered radiation dose To date postoperative dosimetry has primarily been described in terms of V 100150200 volume of the gland receiving 100 150 and 200 of the prescription dose and the D90 the dose delivered to 90 of the prostate gland Following I-125 monotherapy A D90 greater than or equal to 140 Gy day 30 dosimetry is required for optimal long-term biochemical control 4545 A dose of 140 Gy represents 96 of the standard I-125 prescription dose 145 Gy In contrast following Pd-103 monotherapy A D90 greater than or equal to 100 Gy day 30 dosimetry and a D90 greater than or equal to 108 Gy median day 22 dosimetry have been reported to predict optimal biochemical outcomes 6767 These Pd-103 doses represent 80 and 86 of the standard monotherapy prescription dose 125 Gy In addition a prospective randomized trial demonstrated that coverage of 90 or more of the prostate by 124 Gy of Pd-103 yields 98 change of being cancer-free three years following treatment 3
Because of some seed placement uncertainty however the pre-plans are designed to deliver a higher radiation dose than necessary to most of the prostate gland 8 Additionally there is a variable amount of edema that occurs from the implant procedure moving seeds farther away from each other again requiring a higher planned dose than actually needed
Delivered radiation dose is paramount to securing long-term freedom from biochemical progression Previously Merrick and colleagues reported that postoperative dosimetric quality for Pd-103 and I-125 in terms of V 100150200 and D90 were independent of prostate size isotope selection radiation implant dose prescription the use of supplemental external beam radiation therapy neoadjuvant androgen deprivation therapy and patient age 8-1289101112 These results demonstrate the dosimetric reproducibility of Pd-103 across all implant scenarios A review of the last 200 consecutive Pd-103 implants at the Schiffler Cancer Center illustrates similar dosimetric outcomes for patients implanted with 125 Gy versus 115 Gy
Although the morbidity profile of permanent prostate brachytherapy compares favorably with competing local modalities side effects and complications do occur Delivered radiation dose to the urethra rectum and proximal penis strongly correlate with brachytherapy-related morbidity 2 13-18131415161718
In summary the available literature suggests that the Pd-103 doses necessary for cure care substantially less than currently prescribed postoperative dosimetry has consistently demonstrated high intraprostatic doses and brachytherapy-related morbidity is related to radiation doses to normal surrounding structures As such we proposed to conduct a prospective randomized trial evaluating the effect of a 12 reduction in prescription dose 125 Gy vs 110 Gy on the ultimate cure and complication rates for low risk prostate cancer PSA greater than or equal to 10 ngmL Gleason score greater than or equal to 6 and clinical stage T1b-T2b To assure that the dose is adequate intraoperative and postoperative dosimetry will be performed Intraoperative dose evaluation will allow additional seeds to be implanted if needed to achieve minimum required dose
Over the past decade transperineal ultrasound-guided permanent prostate brachytherapy using either Pd-130 or I-125 has been increasingly utilized as definitive management for early stage carcinoma of the prostate gland This resurgence of interest in prostate brachytherapy was the result of several technologic advances including the evolution of transrectal ultrasonography the development of a closed transperineal approach and the availability of sophisticated treatment planning computers These imaging and planning advances significantly improved the accuracy of seed placement In addition the advent of CT-based postoperative dosimetry in the early 1990s provided a unique opportunity to evaluate quality and proactively predict outcome and complications
Prostate brachytherapy represents the ultimate 3-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 122
Although there is no definitive evidence suggesting that either Pd-103 or I-125 is more efficacious than the other in terms of cure or side effectscomplications preliminary results of a prospective randomized trial suggests that Pd-103 may be more dose forgiving than I-125 3 Long-term results demonstrate cancer eradication is highly correlated with delivered radiation dose To date postoperative dosimetry has primarily been described in terms of V 100150200 volume of the gland receiving 100 150 and 200 of the prescription dose and the D90 the dose delivered to 90 of the prostate gland Following I-125 monotherapy A D90 greater than or equal to 140 Gy day 30 dosimetry is required for optimal long-term biochemical control 4545 A dose of 140 Gy represents 96 of the standard I-125 prescription dose 145 Gy In contrast following Pd-103 monotherapy A D90 greater than or equal to 100 Gy day 30 dosimetry and a D90 greater than or equal to 108 Gy median day 22 dosimetry have been reported to predict optimal biochemical outcomes 6767 These Pd-103 doses represent 80 and 86 of the standard monotherapy prescription dose 125 Gy In addition a prospective randomized trial demonstrated that coverage of 90 or more of the prostate by 124 Gy of Pd-103 yields 98 change of being cancer-free three years following treatment 3
Because of some seed placement uncertainty however the pre-plans are designed to deliver a higher radiation dose than necessary to most of the prostate gland 8 Additionally there is a variable amount of edema that occurs from the implant procedure moving seeds farther away from each other again requiring a higher planned dose than actually needed
Delivered radiation dose is paramount to securing long-term freedom from biochemical progression Previously Merrick and colleagues reported that postoperative dosimetric quality for Pd-103 and I-125 in terms of V 100150200 and D90 were independent of prostate size isotope selection radiation implant dose prescription the use of supplemental external beam radiation therapy neoadjuvant androgen deprivation therapy and patient age 8-1289101112 These results demonstrate the dosimetric reproducibility of Pd-103 across all implant scenarios A review of the last 200 consecutive Pd-103 implants at the Schiffler Cancer Center illustrates similar dosimetric outcomes for patients implanted with 125 Gy versus 115 Gy
Although the morbidity profile of permanent prostate brachytherapy compares favorably with competing local modalities side effects and complications do occur Delivered radiation dose to the urethra rectum and proximal penis strongly correlate with brachytherapy-related morbidity 2 13-18131415161718
In summary the available literature suggests that the Pd-103 doses necessary for cure care substantially less than currently prescribed postoperative dosimetry has consistently demonstrated high intraprostatic doses and brachytherapy-related morbidity is related to radiation doses to normal surrounding structures As such we proposed to conduct a prospective randomized trial evaluating the effect of a 12 reduction in prescription dose 125 Gy vs 110 Gy on the ultimate cure and complication rates for low risk prostate cancer PSA greater than or equal to 10 ngmL Gleason score greater than or equal to 6 and clinical stage T1b-T2b To assure that the dose is adequate intraoperative and postoperative dosimetry will be performed Intraoperative dose evaluation will allow additional seeds to be implanted if needed to achieve minimum required dose
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