Prostate CancerProsevenNCT04896801
MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
A study testing MR-guided RT in people with Prostate Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. 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?
- MR-guided RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Aug 2021to Feb 2030
- 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
- Age > 18 y
- Histologically confirmed prostate adenocarcinoma
- Low risk: cT1c-T2a, Gleason score 6, PSA < 10ng/mL
- Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, < 50% positive biopsy cores)
- Unfavorable intermediate risk: > 1 intermediate risk factor, Gleason 4+3, > 50% positive biopsy cores)
- Limited high risk: cT3a with PSA < 40ng/mL or cT2a-c with a Gleason score > 7 and/or a PSA > 20ng/mL but < 40ng/mL
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- World Health Organization performance score 0-2
- Written informed consent
- Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL
Who cannot join
- Transurethral resection (TUR) < 3months before SBRT
- International Prostate Symptom Score (IPSS) > 19
- Prostate volume > 100cc on transrectal ultrasound (TRUS)
- Stage cT3b-T4
- N1 disease (clinically or pathologically)
- M1 disease (clinically or pathologically)
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- PSA > 40ng/mL
- inflammatory bowel disease
- immunosuppressive medications
- prior pelvic RT
- contra-indications for MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jacques Bezuidenhout, MD contact
Belgium1 site, 1 recruiting
- Recruiting
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Brussels
Mark De Ridder, MD, 00324776041, mark.deridder@uzbrussel.be
Ka Lun Law, ka.lun.law@vub.be
About this study
Official title: Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.
- Conditions
- Prostate Cancer
- Being tested
- MR-guided RT
- Keywords
- MR-guided radiotherapy, Stereotactic body 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.
MR-guided RTRadiation
The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy < 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT
| Study group | Role | What they receive |
|---|---|---|
| MR-guided prostate stereotactic body radiotherapy | Experimental | Patients will receive MR-guided RT in 5 fractions over 7 days (daily excluding weekend, i.e. start on Wednesday or Thursday, until Tuesday or Wednesday respectively the week after). Receives: Radiation: MR-guided RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity according to CTCAE v 5.0
Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0
Measured: from the first treatment fraction up to 3 months
Acute toxicity according to RTOG criteria
Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria
Measured: from the first treatment fraction up to 3 months
Secondary outcomes (9)
Late toxicity according to CTCAE v 5.0
Clinician reported late toxicity, assessed using CTCAE v 5.0
Measured: within 5 years after start of radiotherapy
Late toxicity according to RTOG criteria
Clinician reported late toxicity, assessed using RTOG criteria
Measured: within 5 years after start of radiotherapy
Quality of life assessment
Quality of life according to EORTC Quality of life Questionnaire C30
Measured: from the start of radiotherapy until 5 years after treatment
Prostate specific quality of life assessment
Quality of life according to EORTC Quality of life Questionnaire PR25
Measured: from the start of radiotherapy until 5 years after treatment
EPIC-26 quality of life
Quality of life according to Expanded Prostate Index Composite-26 (EPIC-26)
Measured: from the start of radiotherapy until 5 years after treatment
IPSS quality of life
Quality of life according to International Prostate Symptom Score (IPSS)
Measured: from the start of radiotherapy until 5 years after treatment
Freedom from biochemical failure
the Phoenix definition is used to define PSA failure (i.e. nadir + 2ng/mL)
Measured: from start of radiotherapy until PSA relapse, assessed up to 5 years
Disease-free survival
from start of radiotherapy until first evidence of recurrence (loco-regional or distant) or death from any cause
Measured: from start of radiotherapy until 5 years after treatment
Overall survival
from start of radiotherapy until death from any cause
Measured: from start of radiotherapy until 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start10 Aug 2021
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2030 (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.
- More trials run by Universitair Ziekenhuis BrusselThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark De Ridder, Universitair Ziekenhuis Brussel
- Investigators
- Mark De Ridder, MD, Principal investigator, Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896801
- Sponsor's protocol ID
- PRO7
- Acronym
- Proseven
- Status last verified
- Dec 2024
- First submitted
- 13 May 2021
- Last updated
- 4 Dec 2024
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
- ClinicalTrials.gov ID
- NCT04896801
- Acronym / sponsor ID
- Proseven / PRO7
- Conditions
- Prostate Cancer
- Keywords
- MR-guided radiotherapy, Stereotactic body radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 21 May 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.
The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MR-guided prostate stereotactic body radiotherapy | Experimental | Radiation: MR-guided RTPatients will receive MR-guided RT in 5 fractions over 7 days (daily excluding weekend, i.e. start on Wednesday or Thursday, until Tuesday or Wednesday respectively the week after). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 y
- Histologically confirmed prostate adenocarcinoma
- Low risk: cT1c-T2a, Gleason score 6, PSA < 10ng/mL
- Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, < 50% positive biopsy cores)
- Unfavorable intermediate risk: > 1 intermediate risk factor, Gleason 4+3, > 50% positive biopsy cores)
Key exclusion criteria (11 listed)
- Transurethral resection (TUR) < 3months before SBRT
- International Prostate Symptom Score (IPSS) > 19
- Prostate volume > 100cc on transrectal ultrasound (TRUS)
- Stage cT3b-T4
- N1 disease (clinically or pathologically)
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 |
|---|---|---|
| MR-guided RTThe dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy < 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT | Radiation | MR-guided prostate stereotactic body radiotherapy |
Primary outcome
Acute toxicity according to CTCAE v 5.0
Time frame: from the first treatment fraction up to 3 months
Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using CTCAE v 5.0
Acute toxicity according to RTOG criteria
Time frame: from the first treatment fraction up to 3 months
Clinician reported grade 2 or more acute gastrointestinal (GI) or genitourinary (GU) toxicity, assessed using RTOG criteria
9 secondary outcomes
Late toxicity according to CTCAE v 5.0
Time frame: within 5 years after start of radiotherapy
Late toxicity according to RTOG criteria
Time frame: within 5 years after start of radiotherapy
Quality of life assessment
Time frame: from the start of radiotherapy until 5 years after treatment
Prostate specific quality of life assessment
Time frame: from the start of radiotherapy until 5 years after treatment
EPIC-26 quality of life
Time frame: from the start of radiotherapy until 5 years after treatment
IPSS quality of life
Time frame: from the start of radiotherapy until 5 years after treatment
Freedom from biochemical failure
Time frame: from start of radiotherapy until PSA relapse, assessed up to 5 years
Disease-free survival
Time frame: from start of radiotherapy until 5 years after treatment
Overall survival
Time frame: from start of radiotherapy until 5 years after treatment
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 4 Dec 2024.
- 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.
Jacques Bezuidenhout, MD contact
Mark De Ridder, MD principal investigator
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided RT in people with Prostate Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 9 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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 Belgium. 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?
Contact Mark De Ridder, MD (00324776041, mark.deridder@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity according to CTCAE v 5.0 (time frame: from the first treatment fraction up to 3 months). The study lists 2 primary outcomes in all. 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 4 Dec 2024.