Prostate CancerPhase 3NCT00201916
Shorter Radiation Schedule for the Treatment of Prostate Cancer
A Phase 3 study testing 5250 cGy/20 fractions over 28 days and 6600 cGy/33 fractions over 45 days in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 16 sites in Canada.
Trial summary
To improve the management of patients with early stage prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 5250 cGy/20 fractions over 28 days and 6600 cGy/33 fractions over 45 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 16 sitesCanada
- Study dates
- Mar 1995to Dec 2009
- Phase
- Phase 3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
- stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification
Who cannot join
- PSA > 40 mcg/L
- previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
- prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
- simulated volume exceeds 1000 cm3
- previous pelvic radiotherapy
- inflammatory bowel disease
Show all 11Show fewer
- serious non-malignant disease which would preclude radiotherapy or surgical biopsy
- geographic inaccessibility for follow-up
- psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol
- unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy
- failure to give informed consent to participate in the study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Canada16 sites
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Juravinski Cancer Centre
Hamilton, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
London Regional Cancer Centre
London, Ontario, N6A 4L6
Dr. Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Newfoundland Cancer Clinic
St. John's, Newfoundland and Labrador, A1B 3V6
B.C. Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7A 7T1
Toronto-Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network -Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
B. C. Cancer Agency - Vancouver Cancer Clinic
Vancouver, British Columbia, V5Z 4E6
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
To improve the management of patients with early stage prostate cancer.
Read the detailed description
To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.
- Conditions
- Prostate Cancer
- Being tested
- 5250 cGy/20 fractions over 28 days, 6600 cGy/33 fractions over 45 days
- Keywords
- prostate cancer, prostate specific antigen, PSA, radiation fractionation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5250 cGy/20 fractions over 28 daysProcedure or surgery
Also called short fractionation schedule
see above
6600 cGy/33 fractions over 45 daysProcedure or surgery
Also called standard
see above
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5250 cGy in 20 fractions over 28 days Receives: Procedure: 5250 cGy/20 fractions over 28 days |
| 2 | Active comparator | 6600 cGy in 33 fractions over 45 days Receives: Procedure: 6600 cGy/33 fractions over 45 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to PSA failure
Measured: 10 years
Secondary outcomes (5)
positive biopsy at two years post radiation
Measured: see above
disease free survival
Measured: 10 years
toxicity
Measured: 10 years
quality of life
Measured: 6 years
economic
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 1995
- Primary completionDec 2008
- Study completionDec 2009
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- NCIC Clinical Trials Group
- Investigators
- Himu Lukka, MD, Study chair, Juravinski Cancer CentreCharles Hayter, MD, Study chair, Toronto Sunnybrook Regional Cancer CentreMark Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201916
- Sponsor's protocol ID
- OCOG-1995-PR.5
- Other IDs
- CAN-OCOG-V95-0687
- Status last verified
- Aug 2010
- First submitted
- 13 Sep 2005
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, Prichard H, Brundage M, Kwan W. Randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005 Sep 1;23(25):6132-8. doi: 10.1200/JCO.2005.06.153.
PubMed 16135479
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00201916
- Acronym / sponsor ID
- OCOG-1995-PR.5
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate specific antigen, PSA, radiation fractionation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- NCIC Clinical Trials Group
- Study start
- Mar 1995
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 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.
To improve the management of patients with early stage prostate cancer.
Detailed description
To compare the efficacy of a shorter radiation fractionation schedule to the prostate (5250 cGy/20 fractions over 28 days) with a conventional schedule (6600 cGy/33 fractions over 45 days) in men receiving radiotherapy for Stage T1a moderately or poorly differentiated, or T1b, T1c, or T2 prostate cancer. The primary outcome is local control in the prostate and secondary outcomes include toxicity, disease free survival, survival, quality of life and economics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: 5250 cGy/20 fractions over 28 days5250 cGy in 20 fractions over 28 days |
| 2 | Active comparator | Procedure: 6600 cGy/33 fractions over 45 days6600 cGy in 33 fractions over 45 days |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung
- stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification
Key exclusion criteria (11 listed)
- PSA > 40 mcg/L
- previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer
- prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured
- simulated volume exceeds 1000 cm3
- previous pelvic radiotherapy
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 |
|---|---|---|
| 5250 cGy/20 fractions over 28 daysAlso: short fractionation schedulesee above | Procedure or surgery | 1 |
| 6600 cGy/33 fractions over 45 daysAlso: standardsee above | Procedure or surgery | 2 |
Primary outcome
time to PSA failure
Time frame: 10 years
5 secondary outcomes
positive biopsy at two years post radiation
Time frame: see above
disease free survival
Time frame: 10 years
toxicity
Time frame: 10 years
quality of life
Time frame: 6 years
economic
Time frame: 10 years
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 17 Aug 2010.
- Results publication: PubMed 16135479Lukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, Prichard H, Brundage M, Kwan W. Randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005 Sep 1;23(25):6132-8. doi: 10.1200/JCO.2005.06.153.
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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.
Himu Lukka, MD study chair
Juravinski Cancer Centre
Charles Hayter, MD study chair
Toronto Sunnybrook Regional Cancer Centre
Mark Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5250 cGy/20 fractions over 28 days and 6600 cGy/33 fractions over 45 days in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 16 sites 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 2 inclusion and 11 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 17 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 16 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
time to PSA failure (time frame: 10 years). 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 NCT00201916, 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 17 Aug 2010.