Prostate CancerPhase 2AFFIRMNCT05373316
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
A Phase 2 study testing Ultrahypofractionated MR-guided radiotherapy boost in people with Prostate Cancer and Prostate Neoplasm, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm
- What is being tested?
- Ultrahypofractionated MR-guided radiotherapy boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Dec 2022to 1 Jul 2029
- Phase
- Phase 2
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 18 years or older with histologically proven prostate carcinoma
- Imaging stage T3b (as defined on mpMRI) N0M0
- Intraprostatic lesion visible on MRI
- Capable of giving informed consent
Who cannot join
- History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
- Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
- Absence of pre-treatment PSMA PET CT
- WHO performance score > 2
- International Prostate Symptom Score ≥ 15
- PSA > 30
- Prostate volume >100c
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites
Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX
Floris Pos, MD, PhD, +31205129111, f.pos@nki.nl
Radboudumc
Nijmegen, Gelderland, 6525GA
Linda Kerkmeijer, MD, PhD, +31243614505, linda.kerkmeijer@radboudumc.nl
Casper Reijnen, MD, PhD, +31243614505, casper.reijnen@radboudumc.nl
About this study
The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.
This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Being tested
- Ultrahypofractionated MR-guided radiotherapy boost
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrahypofractionated MR-guided radiotherapy boostRadiation
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI.
| Study group | Role | What they receive |
|---|---|---|
| MR-guided hypofractionated focal boost radiotherapy | Experimental | External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MR Receives: Radiation: Ultrahypofractionated MR-guided radiotherapy boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute gastrointestinal and genitourinary toxicity
Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment (e.g. 60 days after completion of the radiation treatment).
Measured: 90 days after start of treatment
Secondary outcomes (7)
Late GI and GU toxicity (CTCAE v5.0)
assessed between 90 days and up to 5 years after the first radiation treatment
Measured: from 90 days after start of treatment up to 5 years
Quality of life
using the EORTC QLQ-C30 questionnaires
Measured: from baseline up to 5 years after completion of treatment
Quality of life
using the EORTC QLQ-PR25 questionnaires
Measured: from baseline up to 5 years after completion of treatment
Biochemical disease free survival
measuring the PSA concentration using the Phoenix definition for biochemical recurrence
Measured: up to 5 years after completion of treatment
Overall survival
Measured: up to 5 years after completion of treatment
Prostate cancer specific survival
Measured: up to 5 years after completion of treatment
Distant metastasis free survival
Measured: up to 5 years after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2029 (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 Radboud University Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373316
- Sponsor's protocol ID
- NL79869.091.22
- Acronym
- AFFIRM
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
- ClinicalTrials.gov ID
- NCT05373316
- Acronym / sponsor ID
- AFFIRM / NL79869.091.22
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 13 May 2022 (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 AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.
This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.
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 hypofractionated focal boost radiotherapy | Experimental | Radiation: Ultrahypofractionated MR-guided radiotherapy boostExternal beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MR |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged 18 years or older with histologically proven prostate carcinoma
- Imaging stage T3b (as defined on mpMRI) N0M0
- Intraprostatic lesion visible on MRI
- Capable of giving informed consent
Key exclusion criteria (7 listed)
- History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
- Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
- Absence of pre-treatment PSMA PET CT
- WHO performance score > 2
- International Prostate Symptom Score ≥ 15
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 |
|---|---|---|
| Ultrahypofractionated MR-guided radiotherapy boostExternal beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI. | Radiation | MR-guided hypofractionated focal boost radiotherapy |
Primary outcome
Acute gastrointestinal and genitourinary toxicity
Time frame: 90 days after start of treatment
Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment (e.g. 60 days after completion of the radiation treatment).
7 secondary outcomes
Late GI and GU toxicity (CTCAE v5.0)
Time frame: from 90 days after start of treatment up to 5 years
Quality of life
Time frame: from baseline up to 5 years after completion of treatment
Quality of life
Time frame: from baseline up to 5 years after completion of treatment
Biochemical disease free survival
Time frame: up to 5 years after completion of treatment
Overall survival
Time frame: up to 5 years after completion of treatment
Prostate cancer specific survival
Time frame: up to 5 years after completion of treatment
Distant metastasis free survival
Time frame: up to 5 years after completion of 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 7 Nov 2022.
- 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.
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 Ultrahypofractionated MR-guided radiotherapy boost in people with Prostate Cancer and Prostate Neoplasm, run by Radboud University Medical Center at 2 sites in Netherlands.
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 7 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: opening soon, as of the sponsor's last update on 7 Nov 2022. 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 Netherlands. 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?
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 Casper Reijnen, MD, PhD (003124 361 4505, casper.reijnen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute gastrointestinal and genitourinary toxicity (time frame: 90 days after start of treatment). 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 7 Nov 2022.