Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2 (FASTR-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02229734|
Recruitment Status : Recruiting
First Posted : September 1, 2014
Last Update Posted : March 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Radiation Drug: Androgen Suppression||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2019|
Experimental: Radiation plus Androgen Supression
Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months
Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)Drug: Androgen Suppression
Leuprolide 45mg every 6 months for a total of 18 months
Other Name: LHRH agonist
- Genitourinary and Gastrointestinal Toxicity at 1 year [ Time Frame: Year 1 of follow-up ]Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
- Disease Free Survival at 3 years [ Time Frame: 1, 2, and 3 years of follow-up ]Defined by absence of clinical relapse and prostatic specific antigen (PSA) failure as per the American Society of Therapeutic Radiation and Oncology (ASTRO) Phoenix definition
- Quality of Life [ Time Frame: 1, 2, and 3 years of follow-up ]Measured using the Prostate Cancer Radiotherapy questionnaire
- Genitourinary and Gastrointestinal Toxicity at 2 years [ Time Frame: Year 2 of follow-up ]
Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria
Safety Issue? (FDAAA) Yes
- Genitourinary and gastrointestinal toxicity measured at 3 years [ Time Frame: Year 3 of follow-up ]Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229734
|Contact: Glenn Bauman, MD||519-685-8650||Glenn.Bauman@lhsc.on.ca|
|London Regional Cancer Program of the Lawson Health Research Institute||Recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Glenn Bauman, MD 519-685-8650 Glenn.Bauman@lhsc.on.ca|
|Principal Investigator: Glenn Bauman, MD|
|Principal Investigator:||Glenn Bauman, MD||London Regional Cancer Program of the Lawson Health Research Institute|