Prostatic NeoplasmPhase 1/2NCT00252447
Preop Conformal Radiotherapy - Prostate
A Phase 1/2 study testing Pre-Operative Conformal Radiotherapy in people with Prostatic Neoplasm, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Pre-Operative Conformal Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- May 2000to Mar 2009
- 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
- Histologically confirmed carcinoma of the prostate
- High risk localized disease defined as clinical T1 or T2 plus [ (i) Gleason ¡Ý7, PSA>10 ng/ml and <35 ng/ml OR (ii) PSA >15 ng/ml and less <35 ng/ml (any Gleason) ]
- No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery
- No evidence of distant metastases on bone scan within 4 months of surgery
- No contraindication to pelvic radiation therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy
Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.
- Conditions
- Prostatic Neoplasm
- Being tested
- Pre-Operative Conformal Radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Operative Conformal RadiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startMay 2000
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Padraig Warde, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252447
- Sponsor's protocol ID
- UHN REB 01-0483-C
- Status last verified
- Aug 2010
- First submitted
- 9 Nov 2005
- Last updated
- 11 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00252447
- Acronym / sponsor ID
- UHN REB 01-0483-C
- Conditions
- Prostatic Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- May 2000
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Nov 2005 (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.
Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Pre-Operative Conformal Radiotherapy | Procedure or surgery | – |
Primary outcome
To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.
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 11 Aug 2010.
Related trials for Prostatic Neoplasm
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Padraig Warde, MD principal investigator
Princess Margaret Hospital, Canada
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 Pre-Operative Conformal Radiotherapy in people with Prostatic Neoplasm, run by University Health Network, Toronto 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?
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 11 Aug 2010. 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?
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?
To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.. 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 11 Aug 2010.