Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-05 @ 6:03 PM
Study NCT ID:
NCT02229734
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
Status:
COMPLETED
Status Verified Date:
2021-06
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:
FASTR-2
Brief Summary:
This study will explore the combination of a stereotactic body radiation therapy (SBRT) approach combined with one year of luteinizing hormone releasing hormone (LHRH) agonist for older men with high risk prostate cancer, or men unwilling to undertake conventionally fractionated therapy and three years of adjuvant hormone therapy.
The purpose of this study is to examine the safety of a shorter course of radiation treatment combined wtih androgen deprivation therapy.
The purpose of this study is to examine the safety of a shorter course of radiation treatment combined wtih androgen deprivation therapy.
Detailed Description:
Randomized controlled trials have established the improved efficacy (better biochemical control and disease free survival) of combined radical radiation (70-80 Gy over 7-8 weeks) combined with long term hormone therapy (2-3 years of adjuvant LHRH agonist) compared to a primary hormone therapy or radiation therapy alone in men with locally advanced/high risk disease. While this approach may be tolerable in fit individuals, this combination may not be well tolerated by frail individuals, or those who live at a distance who may find it difficult to attend for 7 weeks of radiation treatments. Those individuals with co-morbidities such as diabetes, coronary artery disease or osteoporosis may have those conditions exacerbated by long term hormone therapy.
The combination of short course radiation and hormone therapy was explored in the FASTR trial. As part of the trial, patients received 12 months of hormone therapy with radiation treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week) concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1 fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in 5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).
The combination of short course radiation and hormone therapy was explored in the FASTR trial. As part of the trial, patients received 12 months of hormone therapy with radiation treatment to the pelvic lymph nodes (dose of 25 Gy in 5 fractions, 1 fraction per week) concomitant with radiation treatment to the prostate (dose of 40 Gy in 5 fractions, 1 fraction per week). The study was discontinued due to toxicity. For the FASTR-2 study, these concerns are being addressed through the use of a lower total dose to the prostate (35 Gy in 5 fractions, 1 fraction per week). Given the uncertainty of the benefit of pelvic nodal radiation in prostate cancer, it was decided to omit the pelvic nodal radiation in the FASTR-2 study. In addition, given the recent evidence supporting the equivalence of 18 months of hormone therapy, compared to 36 months, it was decided to lengthen the duration of hormone therapy in the FASTR-2 study to 18 months (versus 12 months in the FASTR study).
Study Oversight
Has Oversight DMC:
True
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?: