Prostate CancerPhase 2FASTR-2NCT02229734
Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
A Phase 2 study testing Radiation and Androgen Suppression in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiation and Androgen Suppression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to 1 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- High risk prostate cancer
- Has had multidisciplinary consultation with radiation oncologist and urologist
- Age >70 or refuses standard treatment
- No evidence of extra-prostatic disease on screening bone scan and CT scan (non-contrast CT used for CT simulation acceptable)
- Signed written and voluntary informed consent provided.
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Patients not meeting the eligibility criteria
- Prior pelvic radiotherapy or brachytherapy
- Use of anti-coagulation (low molecular weight heparin or Coumadin)
- History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)
- Previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
- patients on androgen deprivation therapy > 2 months prior to study enrolment
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 4L6
About this study
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.
Read the 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).
- Conditions
- Prostate Cancer
- Being tested
- Radiation, Androgen Suppression
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)
Androgen SuppressionDrug
Also called LHRH agonist
Leuprolide 45mg every 6 months for a total of 18 months
| Study group | Role | What they receive |
|---|---|---|
| Radiation plus Androgen Supression | Experimental | Radiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months Receives: Radiation: Radiation; Drug: Androgen Suppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genitourinary and Gastrointestinal Toxicity at 1 year
Genitourinary and gastrointestinal toxicity measured at year 1 of follow-up using the Common Toxicity Criteria
Measured: Year 1 of follow-up
Secondary outcomes (4)
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
Measured: 1, 2, and 3 years of follow-up
Quality of Life
Measured using the Prostate Cancer Radiotherapy questionnaire
Measured: 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
Measured: 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
Measured: Year 3 of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2017
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn Bauman, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Glenn Bauman, MD, Principal investigator, London Regional Cancer Program of the Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229734
- Sponsor's protocol ID
- FASTR-2
- Acronym
- FASTR-2
- Status last verified
- Jun 2021
- First submitted
- 27 Aug 2014
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bauman G, Ferguson M, Lock M, Chen J, Ahmad B, Venkatesan VM, Sexton T, D'Souza D, Loblaw A, Warner A, Rodrigues G. A Phase 1/2 Trial of Brief Androgen Suppression and Stereotactic Radiation Therapy (FASTR) for High-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):856-62. doi: 10.1016/j.ijrobp.2015.02.046. Epub 2015 Apr 30.
PubMed 25936597
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer - Protocol 2
- ClinicalTrials.gov ID
- NCT02229734
- Acronym / sponsor ID
- FASTR-2 / FASTR-2
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation plus Androgen Supression | Experimental | Radiation: Radiation, Drug: Androgen SuppressionRadiation plus Androgen Suppression give as stereotactic radiation 7gray (Gy) per week x 5 weeks and leuprolide 45mg every 6 months for 18 months |
Who may qualify
- Ages
- 70 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- High risk prostate cancer
- Has had multidisciplinary consultation with radiation oncologist and urologist
- Age >70 or refuses standard treatment
- No evidence of extra-prostatic disease on screening bone scan and CT scan (non-contrast CT used for CT simulation acceptable)
- Signed written and voluntary informed consent provided.
Key exclusion criteria (6 listed)
- Patients not meeting the eligibility criteria
- Prior pelvic radiotherapy or brachytherapy
- Use of anti-coagulation (low molecular weight heparin or Coumadin)
- History of inflammatory bowel disease, Crohn's disease, diverticulitis or collagen vascular disease (other than rheumatoid arthritis)
- Previous treatment for malignancy (other than basal or squamous cell skin cancer) within 3 years of prostate cancer diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationRadiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy) | Radiation | Radiation plus Androgen Supression |
| Androgen SuppressionAlso: LHRH agonistLeuprolide 45mg every 6 months for a total of 18 months | Drug | Radiation plus Androgen Supression |
Primary outcome
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
4 secondary outcomes
Disease Free Survival at 3 years
Time frame: 1, 2, and 3 years of follow-up
Quality of Life
Time frame: 1, 2, and 3 years of follow-up
Genitourinary and Gastrointestinal Toxicity at 2 years
Time frame: Year 2 of follow-up
Genitourinary and gastrointestinal toxicity measured at 3 years
Time frame: Year 3 of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 25936597Bauman G, Ferguson M, Lock M, Chen J, Ahmad B, Venkatesan VM, Sexton T, D'Souza D, Loblaw A, Warner A, Rodrigues G. A Phase 1/2 Trial of Brief Androgen Suppression and Stereotactic Radiation Therapy (FASTR) for High-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):856-62. doi: 10.1016/j.ijrobp.2015.02.046. Epub 2015 Apr 30.
- Preliminary Results and Toxicity AnalysisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Bauman, MD principal investigator
London Regional Cancer Program of the Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation and Androgen Suppression in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genitourinary and Gastrointestinal Toxicity at 1 year (time frame: Year 1 of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02229734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.