Prostate CancerPhase 2PBSNCT03380806
Prostate Boost Irradiation With Stereotactic Body RT (SBRT)
A Phase 2 study testing LHRH agonist, Pelvic Radiation and Stereotactic Body Radiotherapy (SBRT) in people with Prostate Cancer, run by Juravinski Cancer Center at 2 sites in Canada.
Trial summary
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- LHRH agonist, Pelvic Radiation and Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2019to 1 Jan 2022
- Phase
- Phase 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 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;)
- No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease)
- Patient is able to complete the quality of life questionnaires in English.
- Informed consent obtained
Who cannot join
- • Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date;
- Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy;
- Patients previously on more than twelve weeks of hormone therapy for their PrCa;
- Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years;
- Contraindications to placement of gold seeds for daily prostate localization;
- Previous pelvic RT and/or significant pelvic surgery;
Show all 12Show fewer
- Severe diverticular or inflammatory bowel disease (as determined by the treated radiation oncologist)
- Previous hip replacement
- PSA over 50
- IPSS 20 or higher
- TRUS-based prostate
- volume of > 80 cc
Trial locations and contacts
2 sites in 1 country.
Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC contact
Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC contact
Canada2 sites, 2 recruiting
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario
Theodorous Tsakiridis, MD, FRPC
Naghmeh Isfahanian, MD, FRCPC
- Recruiting
Walker Family Cancer Centre ,Niagara Health - St. Catharines Site
St. Catharines, Ontario
Theodoros Tsakiridis, MD, FRCPC
About this study
Official title: A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.
Read the detailed description
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.
- Conditions
- Prostate Cancer
- Being tested
- LHRH agonist, Pelvic Radiation, Stereotactic Body Radiotherapy (SBRT), Conventional Radiotherapy (CRT) Prostate Boost
- Keywords
- stereotactic body radiotherapy (SBRT), conventional radiotherapy (CRT), High risk prostate cancer, quality of life (QoL), The Expanded Prostate cancer Index Composite (EPIC-26), International Prostate Symptom Score (IPSS)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHRH agonistDrug
Also called Eligard
Standard LHRH agonist for 3 years
Pelvic RadiationRadiation
Pelvic Radiation
Stereotactic Body Radiotherapy (SBRT)Radiation
SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
Conventional Radiotherapy (CRT) Prostate BoostRadiation
CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Conventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist Receives: Drug: LHRH agonist; Radiation: Pelvic Radiation; Radiation: Conventional Radiotherapy (CRT) Prostate Boost |
| Arm 2 | Experimental | Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist Receives: Drug: LHRH agonist; Radiation: Pelvic Radiation; Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Term Quality of Life (QoL)
To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome
Measured: up to 6 months post radiation
Secondary outcomes (3)
Long Term Quality of Life (QoL)
long term QoL QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals up to 24 months month after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome
Measured: 24 months
Urinary function assessment
short and long term quality of urinary function (The International Prostate Symptom Score (IPSS)).
Total IPSS is between 1-35 / lower score shows better function.
Measured: 24 months
Late Toxicity
Grade 2-4 treatment related late (12-24 months), bladder and bowel related toxicity evaluated by the Expanded Common Toxicity Criteria of the National Cancer Institute of Canada (NCI)
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juravinski Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Naghmeh Isfahanian, Juravinski Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380806
- Sponsor's protocol ID
- 4178
- Acronym
- PBS
- Status last verified
- Jun 2020
- First submitted
- 13 Dec 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gouveia A, Mesci A, Isfahanian N, Dayes I, Quan K, Goldberg M, Schnarr KL, Lukka H, Cuthbert D, Hallock A, Douvi G, Wright J, Swaminath A, Chow T, Diamond K, Hajdok G, Maharaj L, Ewusie J, Tsakiridis T. Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer. Prostate. 2025 Jul;85(10):977-985. doi: 10.1002/pros.24905. Epub 2025 Apr 27.
PubMed 40287937
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)
- ClinicalTrials.gov ID
- NCT03380806
- Acronym / sponsor ID
- PBS / 4178
- Conditions
- Prostate Cancer
- Keywords
- stereotactic body radiotherapy (SBRT), conventional radiotherapy (CRT), High risk prostate cancer, quality of life (QoL), The Expanded Prostate cancer Index Composite (EPIC-26), International Prostate Symptom Score (IPSS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Juravinski Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 21 Dec 2017 (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.
A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.
Detailed description
In this study we investigate stereotactic body radiotherapy (SBRT) as a boost radiotherapy treatment, following pelvic radiotherapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiotherapy (CRT) of 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) (comparator arm) or SBRT boost treatment of 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: LHRH agonist, Radiation: Pelvic Radiation, Radiation: Conventional Radiotherapy (CRT) Prostate BoostConventional Radiotherapy (CRT) Prostate Boost Pelvic Radiation LHRH agonist |
| Arm 2 | Experimental | Drug: LHRH agonist, Radiation: Pelvic Radiation, Radiation: Stereotactic Body Radiotherapy (SBRT)Stereotactic Body Radiotherapy (SBRT) Prostate Boost Pelvic Radiation LHRH agonist |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological and or clinical diagnosis of high risk adenocarcinoma of the prostate within six months of entry (stage T3 or higher and/or Gleason score 8 or higher and/or initial PSA level above 20;)
- No radiographic evidence of metastatic disease to the abdomen, lymph nodes, bone or other distant organs; determined by standard staging investigations (bone scan and CT-scan of the abdomen and pelvis) or incidental findings (localized N0, M0 disease)
- Patient is able to complete the quality of life questionnaires in English.
- Informed consent obtained
Key exclusion criteria (12 listed)
- • Histological diagnosis of carcinoma of the prostate more than six months prior to potential registration date;
- Previous treatment for carcinoma of the prostate (other than biopsy or TURP), including bilateral orchiectomy;
- Patients previously on more than twelve weeks of hormone therapy for their PrCa;
- Past history of other malignancies except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for more than 3 years;
- Contraindications to placement of gold seeds for daily prostate localization;
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 |
|---|---|---|
| LHRH agonistAlso: EligardStandard LHRH agonist for 3 years | Drug | Arm 1, Arm 2 |
| Pelvic RadiationPelvic Radiation | Radiation | Arm 1, Arm 2 |
| Stereotactic Body Radiotherapy (SBRT)SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days) | Radiation | Arm 2 |
| Conventional Radiotherapy (CRT) Prostate BoostCRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days) | Radiation | Arm 1 |
Primary outcome
Short Term Quality of Life (QoL)
Time frame: up to 6 months post radiation
To compare early QoL (up to 6 months post RT) in patients with high risk adenocarcinoma of the prostate treated with ADT and RT in the form of pelvic nodal irradiation and prostate boost with standard fractionation, or pelvic nodal irradiation and prostate boost with SBRT using Cyberknife or VMAT. QoL, defined as bowel and bladder function and bother after PrCa treatment, will be measured prior to and at regular intervals after completion of radiotherapy using the established Prostate QoL (The Expanded Prostate cancer Index Composite (EPIC-26 instrument)). Higher EPIC score represent a better outcome
3 secondary outcomes
Long Term Quality of Life (QoL)
Time frame: 24 months
Urinary function assessment
Time frame: 24 months
Late Toxicity
Time frame: 12-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 40287937Gouveia A, Mesci A, Isfahanian N, Dayes I, Quan K, Goldberg M, Schnarr KL, Lukka H, Cuthbert D, Hallock A, Douvi G, Wright J, Swaminath A, Chow T, Diamond K, Hajdok G, Maharaj L, Ewusie J, Tsakiridis T. Primary Analysis of (NCT03380806) a Phase II Randomized Trial of Stereotactic Body Radiotherapy Boost Versus Conventional Fractionation External Beam Radiotherapy Boost in Unfavorable-Intermediate and High-Risk Prostate Cancer. Prostate. 2025 Jul;85(10):977-985. doi: 10.1002/pros.24905. Epub 2025 Apr 27.
- Individual participant dataSharing planned: Undecided
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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.
Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC contact
Naghmeh Isfahanian, Junior Principle Investigator, MD, FRCPC contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LHRH agonist, Pelvic Radiation and Stereotactic Body Radiotherapy (SBRT) in people with Prostate Cancer, run by Juravinski Cancer Center at 2 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 4 inclusion and 12 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Contact Theos Tsakiridis, Senior Principle Investigator, MD, FRCPC (905-387-9495, theos.tsakiridis@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Term Quality of Life (QoL) (time frame: up to 6 months post radiation). 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 NCT03380806, 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 4 Jun 2020.