Prostate CancerPhase 1/2pHART8NCT01505075
Safety and Efficacy Study of Hypofractionated Radiotherapy and Androgen Deprivation Therapy for Prostate Cancer
A Phase 1/2 study testing Hypofractionated radiation in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Sep 2021
- Phase
- Phase 1/2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent obtained
- men > 18 years
- histologically confirmed prostate adenocarcinoma (centrally reviewed)
- high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA > 20ng/mL
Who cannot join
- prior pelvic radiotherapy
- anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- diagnosis of bleeding diathesis
- pelvic girth > 40cm (to ensure visibility of gold seeds on electronic portal imaging)
- large prostate (> 90cm3) on imaging
- severe lower urinary tract symptoms (International Prostate Symptom Score >19 or nocturia > 3)
- No evidence of castrate resistance (defined as PSA < 3ng/mL while testosterone is < 0.7nmol/L). Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression
Trial locations and contacts
1 site in 1 country.
Canada1 site
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).
Read the detailed description
Primary Endpoints:
- Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities
Secondary Endpoints:
- Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities
- Biochemical disease-free survival
- Biopsy positive rate at 3 years
- Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
- Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated radiation
- Keywords
- prostatic neoplasms, radiotherapy, hypofractionated, high risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiationRadiation
Also called RapidArc
40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiation | Experimental | 40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles Receives: Radiation: Hypofractionated radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: Acute period (up to 3 months)
Secondary outcomes (4)
Incidence of grade 3+ urinary toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: Acute (up to 3 months) and Late (after 6 months of follow-up)
Quality of Life
Expanded Prostate Cancer Index Composite (EPIC)
Measured: 5 years
Biochemical (ie.prostate specific antigen) disease free survival
Measured: 5 years
Incidence of grade 3+ rectal toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Measured: Late (after 6 months 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 posted6 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Loblaw, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences CentreSuneil Jain, MD, Principal investigator, suneil.jain@sunnybrook.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505075
- Sponsor's protocol ID
- 043-2011
- Acronym
- pHART8
- Status last verified
- Nov 2020
- First submitted
- 5 Oct 2011
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Dose-escalated, Hypofractionated Radiotherapy and Androgen Deprivation Therapy for High-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01505075
- Acronym / sponsor ID
- pHART8 / 043-2011
- Conditions
- Prostate Cancer
- Keywords
- prostatic neoplasms, radiotherapy, hypofractionated, high risk prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2011 (actual)
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 6 Jan 2012 (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.
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (40Gy/5 fractions/29 days) for the treatment of high risk prostate cancer currently being managed with primary androgen deprivation therapy (PADT).
Detailed description
Primary Endpoints:
- Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 toxicities
Secondary Endpoints:
- Late GI and GU Radiation Therapy Oncology Group (RTOG) toxicities
- Biochemical disease-free survival
- Biopsy positive rate at 3 years
- Quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
- Develop a biobank of DNA and serum extracted from blood and urine to analyze and develop new biomarkers for prostate cancer progression or susceptibility to severe toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiation | Experimental | Radiation: Hypofractionated radiation40 Gy in 5 fractions over 29 to prostate; 30 Gy in 5 fractions over 29 days to seminal vesicles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent obtained
- men > 18 years
- histologically confirmed prostate adenocarcinoma (centrally reviewed)
- high risk prostate cancer, defined as at least one of: clinical stage T3, or gleason score 8-10, or PSA > 20ng/mL
Key exclusion criteria (7 listed)
- prior pelvic radiotherapy
- anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- diagnosis of bleeding diathesis
- pelvic girth > 40cm (to ensure visibility of gold seeds on electronic portal imaging)
- large prostate (> 90cm3) on imaging
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 |
|---|---|---|
| Hypofractionated radiationAlso: RapidArc40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days | Radiation | Hypofractionated radiation |
Primary outcome
Incidence of grade 3+ rectal toxicity
Time frame: Acute period (up to 3 months)
Common Terminology Criteria for Adverse Events (CTCAE) v3.0
4 secondary outcomes
Incidence of grade 3+ urinary toxicity
Time frame: Acute (up to 3 months) and Late (after 6 months of follow-up)
Quality of Life
Time frame: 5 years
Biochemical (ie.prostate specific antigen) disease free survival
Time frame: 5 years
Incidence of grade 3+ rectal toxicity
Time frame: Late (after 6 months of follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Andrew Loblaw, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
Suneil Jain, MD principal investigator
suneil.jain@sunnybrook.ca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypofractionated radiation in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Nov 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Incidence of grade 3+ rectal toxicity (time frame: Acute period (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2020.