High-risk Prostate CancerCHIRPNCT01488968
Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
A study testing Standard Radiation Treatment and Hypofractionated radiation treatment in people with High-risk Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-risk Prostate Cancer
- What is being tested?
- Standard Radiation Treatment and Hypofractionated radiation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to 15 Oct 2018
- Phase
- Interventional
- 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
- Patient is 18 years of age or older
- Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
- Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
- No clinical or radiological evidence of nodal or distant metastasis(es).
- In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
- Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
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- No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
- No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
- No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is > 80%.
- Patient signed informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.
Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.
- Conditions
- High-risk Prostate Cancer
- Being tested
- Standard Radiation Treatment, Hypofractionated radiation treatment
- Keywords
- high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Radiation TreatmentRadiation
39 radiation treatments
Hypofractionated radiation treatmentRadiation
25 radiation treatments
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Standard Radiation Treatment Receives: Radiation: Standard Radiation Treatment |
| Hypofractionated | Experimental | Hypofractionated Receives: Radiation: Hypofractionated radiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
Measured: 5 years
Secondary outcomes (2)
The biochemical control (freedom from PSA failure) rate
Measured: 10 years
Disease free survival
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 posted9 Dec 2011 (estimated)
- Study startMar 2012
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Murtha, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488968
- Sponsor's protocol ID
- 25859
- Acronym
- CHIRP
- Status last verified
- Jan 2017
- First submitted
- 2 Dec 2011
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT01488968
- Acronym / sponsor ID
- CHIRP / 25859
- Conditions
- High-risk Prostate Cancer
- Keywords
- high risk prostate cancer, hypofractionated radiation treatment, higher biological doses, acceptable rectal toxicity, Radiation Treatment
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 111 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 9 Dec 2011 (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.
Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Radiation: Standard Radiation TreatmentStandard Radiation Treatment |
| Hypofractionated | Experimental | Radiation: Hypofractionated radiation treatmentHypofractionated |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is 18 years of age or older
- Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
- Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
- No clinical or radiological evidence of nodal or distant metastasis(es).
- In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard Radiation Treatment39 radiation treatments | Radiation | Standard |
| Hypofractionated radiation treatment25 radiation treatments | Radiation | Hypofractionated |
Primary outcome
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
Time frame: 5 years
2 secondary outcomes
The biochemical control (freedom from PSA failure) rate
Time frame: 10 years
Disease free survival
Time frame: 10 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
Albert Murtha principal investigator
Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Radiation Treatment and Hypofractionated radiation treatment in people with High-risk Prostate Cancer, run by AHS Cancer Control Alberta 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 10 inclusion and 0 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: stopped early, as of the sponsor's last update on 29 Jun 2025. 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.
Are results available for this study?
The study was stopped early. 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?
The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients (time frame: 5 years). 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 29 Jun 2025.