A Phase 2 interventional study of Radiation and Androgen Suppression in Prostate Cancer, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to male participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-06-04.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 2, Interventional, and Treatment
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.
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).
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 351 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Radiation · Drug: Androgen Suppression
Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)
Leuprolide 45mg every 6 months for a total of 18 months
Also known as: LHRH agonist
Genitourinary and Gastrointestinal Toxicity at 1 year
Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
Time frame: Year 1 of follow-up
Disease Free Survival at 3 years
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
Time frame: 1, 2, and 3 years of follow-up
Quality of Life
Measured using the Prostate Cancer Radiotherapy questionnaire
Time frame: 1, 2, and 3 years of follow-up
Genitourinary and Gastrointestinal Toxicity at 2 years
Genitourinary and gastrointestinal toxicity measured at year 2 of follow-up using the Common Toxicity Criteria Safety Issue? (FDAAA) Yes
Time frame: Year 2 of follow-up
Genitourinary and gastrointestinal toxicity measured at 3 years
Genitourinary and gastrointestinal toxicity measured at year 3 of follow-up using the Common Toxicity Criteria
Time frame: Year 3 of follow-up
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's →