Prostate CancerPLUTO-MPCNCT04848909
Stereotactic Body Radiotherapy (SBRT) Post Prostatectomy
A study testing stereotactic body radiotherapy (SBRT) in people with Prostate Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation. 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?
- stereotactic body radiotherapy (SBRT)
- 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
- 3 Jun 2021to Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
- Completed written informed consent
- Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
- A detectable PSA ≤ 2.0 ng/ml
- Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA
Who cannot join
- Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
- Histological or radiological node +ve (N1) or distant metastases (M1)
- Prior pelvic radiotherapy
- Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
Read the detailed description
Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.
- Conditions
- Prostate Cancer
- Being tested
- stereotactic body radiotherapy (SBRT)
- Keywords
- SBRT, Ultrahypofractionated Radiotherapy, Localized 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.
stereotactic body radiotherapy (SBRT)Radiation
Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.
| Study group | Role | What they receive |
|---|---|---|
| Men with prostate cancer post-prostatectomy | Experimental | Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation. Receives: Radiation: stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Adverse Events/toxicities experience by Participants
Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 6.5 years
Secondary outcomes (5)
Late Adverse Events/toxicities experienced by Participants
Incidence of late GU and GI toxicities (≥6 months) using CTCAE v5.0
Measured: 6.5 years
Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire
Acute and late GU and GI quality of life (QoL) using the Expanded Prostate Cancer Index Composite questionnaire which evaluates participant's function and bother after prostate cancer treatment. Each question is scored from 1-5, 1 being the better outcome and 5 being the worst outcome.
Measured: 6.5 years
Biochemical disease-free survival
Biochemical disease-free survival (bDFS), defined as survival until first evidence of either biochemical progression (PSA of 0.4 ng/mL or greater) following postoperative radiotherapy, PSA of more than 2.0 ng/mL at any time after postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol hormone therapy, or death from prostate cancer
Measured: 6.5 years
Health Utilities using The Patient-Oriented Prostate Utility Scale
Health utilities using The Patient-Oriented Prostate Utility Scale to measure health-related quality of life, whether it improves, deteriorates or stay the same. There are 10 questions, each questions has 5 possible answers, with 1 being the better outcome and 5 being the worst outcome.
Measured: 6.5years
Health Utilities using EuroQol- 5 Dimension Questionnaire
Health utilities using the EuroQol- 5 Dimension Questionnaire determines 5 variables, each with 5 possible options, with the first being the best outcome and the last being the worst outcome. The 5 variables include:
- Mobility
- Self-care
- Usual Activities
- Pain/discomfort
- Anxiety/depression
Measured: 6.5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start3 Jun 2021
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- men diagnosed with prostate cancer post-prostatectomy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Victoria Regional Health Centre, Princess Margaret Hospital, Canada, Credit Valley Hospital
- Responsible party
- Principal investigator, Chia-Lin (Eric) Tseng, Sunnybrook Health Sciences Centre
- Investigators
- Dr. Chia-Lin Tseng, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848909
- Sponsor's protocol ID
- 3596
- Acronym
- PLUTO-MPC
- Status last verified
- May 2025
- First submitted
- 12 Apr 2021
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
- ClinicalTrials.gov ID
- NCT04848909
- Acronym / sponsor ID
- PLUTO-MPC / 3596
- Conditions
- Prostate Cancer
- Keywords
- SBRT, Ultrahypofractionated Radiotherapy, Localized Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Royal Victoria Regional Health Centre, Princess Margaret Hospital, Canada, Credit Valley Hospital
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 19 Apr 2021 (actual)
- 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 phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
Detailed description
Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- men diagnosed with prostate cancer post-prostatectomy
| Arm | Type | Receives |
|---|---|---|
| Men with prostate cancer post-prostatectomy | Experimental | Radiation: stereotactic body radiotherapy (SBRT)Men with localized prostate cancer who are considered candidates for post-prostatectomy radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
- Completed written informed consent
- Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
- A detectable PSA ≤ 2.0 ng/ml
- Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA
Key exclusion criteria (4 listed)
- Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
- Histological or radiological node +ve (N1) or distant metastases (M1)
- Prior pelvic radiotherapy
- Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
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 |
|---|---|---|
| stereotactic body radiotherapy (SBRT)Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day. | Radiation | Men with prostate cancer post-prostatectomy |
Primary outcome
Early Adverse Events/toxicities experience by Participants
Time frame: 6.5 years
Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
5 secondary outcomes
Late Adverse Events/toxicities experienced by Participants
Time frame: 6.5 years
Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire
Time frame: 6.5 years
Biochemical disease-free survival
Time frame: 6.5 years
Health Utilities using The Patient-Oriented Prostate Utility Scale
Time frame: 6.5years
Health Utilities using EuroQol- 5 Dimension Questionnaire
Time frame: 6.5years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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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.
Dr. Chia-Lin Tseng, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body radiotherapy (SBRT) 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Early Adverse Events/toxicities experience by Participants (time frame: 6.5 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 15 May 2025.