Prostate AdenocarcinomaProstate-SIBNCT05599737
Stereotactic Prostate Radiotherapy With Dose Escalation Focused on the "Dominant Intra-prostatic Lesion" (DIPL) Delineated by Multi-parametric MRI and 68Ga-PSMA PET (Prostate-SIB-PSMA)
A study testing Integrated boost in people with Prostate Adenocarcinoma, run by Centre Leon Berard at 4 sites in France.
Trial summary
In localized intermediate- and high-risk prostate cancers (according to the NCCN classification), external radiotherapy delivering a "high" dose (dose equivalent 78-80Gy EQD2, α/ß=1.5) to the entire prostate volume combined with hormonal treatment, if necessary, has shown its benefit in terms of recurrence-free… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Integrated boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 24 May 2022to 25 May 2024
- 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 whose age is ≥ 18 years;
- Patient with intermediate-risk or high-risk prostate adenocarcinoma with a single severity criterion based on the NCCN classification
- Patient with at least 12 randomized biopsies
- N0 staging (CT or MRI or PET - choline) M0 (bone scan or PET - choline) with imaging workup less than 6 months old
- Dominant intra-prostate lesion identifiable on a recent multi-parametric MRI (< = 6 months) with an estimated volume < 40% of the entire prostate volume
- Informed patient who has signed a consent to participate in the study
- Patient enrolled in a health insurance plan (or beneficiary of such a plan)
Who cannot join
- Patient with pre-therapeutic micturition disorders (IPSS score > 15)
- Patient with digestive inflammatory disease
- Patient with high risk prostate adenocarcinoma with more than one severity criteria based on the NCCN classification
- Prostate volume > 60 cc
- Patient with hip replacement
- Patient with a contraindication to the implantation of fiduciary implants (anticoagulants that cannot be stopped for gold bead implantation)
Show all 15Show fewer
- Patient with a contraindication to MRI
- Patient who has had a trans-urethral resection of the prostate within 3 months prior to inclusion
- History of previous pelvic radiotherapy
- Patient with previous hormonal treatment
- Known hypersensitivity to the active substance or to the excipients used for the 68Ga-PSMA PET
- Patient with a contraindication to the administration of Lasilix
- Patient for whom follow-up does not seem feasible even in the short term
- Patient participating in another clinical trial that may interfere with the evaluation of the primary endpoint
- Patient under guardianship or deprived of liberty.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Not yet recruiting
CAC-Clermont-Ferrand - Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, 63000
Florent GUILLEMIN, MD, 04 73 27 80 80, florent.GUILLEMIN@clermont.unicancer.fr
- Not yet recruiting
Hospices Civils de Lyon (Hôpital Edouard Herriot)
Lyon, Rhône, 69003
Olivier ROUVIERE, MD, PhD, olivier.rouviere@chu-lyon.fr
- Recruiting
Centre Léon Bérard
Lyon, Rhône, 69373
Pascal POMMIER, MD, 04 78 78 51 66, pascal.pommier@lyon.unicancer.fr
- Not yet recruiting
Centre Marie Curie
Valence, Drôme, 26000
Jean-Baptiste GUY, MD, PhD, 04 75 81 33 81, dr.guy@cmc-valence.org
About this study
In localized intermediate- and high-risk prostate cancers (according to the NCCN classification), external radiotherapy delivering a "high" dose (dose equivalent 78-80Gy EQD2, α/ß=1.5) to the entire prostate volume combined with hormonal treatment, if necessary, has shown its benefit in terms of recurrence-free survival and is considered a standard treatment for this indication.
Two fractionation modalities (number of sessions) are considered as therapeutic standards, conventional fractionation (39 to 40 sessions of 2 Gy in 8 weeks) and moderate hypo-fractionation (20 sessions of 3 Gy). More recently, phase II and two phase III studies have shown equivalence in terms of safety and efficacy of "extreme hypofractionation" (5 or 6 sessions) for these localized cancers, using stereotactic-type techniques. In view of the current data, this fractionation is considered a therapeutic standard in some countries (notably the USA) and an option in France.
Read more
Delivering higher doses, beyond 80 GyEQD2 would improve tumor control, as demonstrated by randomized studies using brachytherapy, but at the cost of an increased risk of urinary toxicity.
As an alternative to this combination of external radiotherapy and brachytherapy, an innovative approach of external radiotherapy has been developed to increase the therapeutic ratio of patients with localized prostate cancer, based on an escalation of the radiation dose (> 95 GyEQD2) focused on the macroscopic tumor or "dominant intra-prostatic lesion" (DIPL), the area most at risk of local recurrence after conventional dose radiotherapy (3). This external radiotherapy technique consists in performing a conventional dose irradiation on the whole prostate, with at the same time (at each session) a higher dose ("Boost") on the DIPL. This is a modality known as "simultaneous integrated boost" (SIB).
The feasibility of simultaneous integrated boost (SIB) on the DIPL has been proven in external radiotherapy using conventional fractionation in the phase III FLAME study and the results in terms of long-term tumor control of this study showed a benefit in terms of biological recurrence-free survival.
Feasibility in terms of tolerance has also been established for very hypofractionated regimens (5 sessions), in particular in the HypoFLAME study that followed the above-mentioned study .
Multiparametric MRI (mpMRI) is used to identify and delineate the "dominant intra-prostatic lesion" (DIPL), and is the most commonly used modality in clinical studies that have evaluated SIB techniques.
However, several studies show that PET imaging, particularly 68Ga-PSMA PET, significantly improves the correlation between the image-defined DIPL and histological data and may improve the likelihood of tumor control. A dosimetric simulation study also showed that dose escalation based on 68Ga-PSMA PET could improve local tumor control with an acceptable level of toxicity .
Moreover, 68Ga-PSMA PET could be used to select the patients who could benefit most from this dose escalation, by excluding patients with lymph node or distant metastases.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Integrated boost
- Keywords
- Localized, Intermediate risk, Initial care, Not operated, Integrated boost, multiparametric MRI, Dominant Intra-Prostatic Lesion (DIPL), 68Ga-PSMA PET, Safety, Dosimetric planning, Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated boostRadiation
Integrated boost based on the dominant intra-prostatic lesion delineated on multi-parametric Magnetic Resonance Imaging and 68Ga-Prostate Specific Membrane Antigen Positron Emission Tomography
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | Stereotactic radiotherapy in 5 fractions (on alternate day)
* Whole prostate: 36.25 Gy - 7.25Gy/fraction
* GTV-RT (boost): target 50 Gy - 10 Gy/fraction Receives: Radiation: Integrated boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of the treatment regimen
Rate of patients with at least one acute toxicity ≥ grade 3 occurring up to 3 months post RT or one late toxicity ≥ grade 2 occurring from 3 months post RT according to the NCI-CTC-v5.0 scale and attributable to radiotherapy (Gastrointestinal or genitourinary toxicities)
Measured: 12 Months
Secondary outcomes (5)
Change in the stage of the disease
Proportion of patients excluded following 68Ga-PSMA PET (non-localised cancers or Index Tumour > 40% of prostate volume)
Measured: 5-10 days after trustee implantation
Dosimetric feasibility
Dose delivered on DIPL and proportion of patients for whom dose escalation ≥ 95 GyEQD2 is possible
Measured: During RT
Adaptability of the 68Ga-PSMA PET preparation protocol to dosimetric planning
Confirmation that the 68Ga-PSMA PET preparation protocol is suitable for dosimetric planning
Measured: Before RT
All grades toxicity
Rate of all grades of toxicity according to NCI-CTC-v5.0
Measured: 12 Months
Tumour control
Rate of patients with recurrence (biological, local or distant)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start24 May 2022
- Primary completion25 May 2024 (estimated)
- Study completion25 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599737
- Sponsor's protocol ID
- ET21-129
- Acronym
- Prostate-SIB
- Status last verified
- May 2022
- First submitted
- 26 Oct 2022
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Prostate Radiotherapy With Dose Escalation Focused on the "Dominant Intra-prostatic Lesion" (DIPL) Delineated by Multi-parametric MRI and 68Ga-PSMA PET (Prostate-SIB-PSMA)
- ClinicalTrials.gov ID
- NCT05599737
- Acronym / sponsor ID
- Prostate-SIB / ET21-129
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Localized, Intermediate risk, Initial care, Not operated, Integrated boost, multiparametric MRI, Dominant Intra-Prostatic Lesion (DIPL), 68Ga-PSMA PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 25 May 2024 (estimated)
- First posted
- 31 Oct 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.
In localized intermediate- and high-risk prostate cancers (according to the NCCN classification), external radiotherapy delivering a "high" dose (dose equivalent 78-80Gy EQD2, α/ß=1.5) to the entire prostate volume combined with hormonal treatment, if necessary, has shown its benefit in terms of recurrence-free survival and is considered a standard treatment for this indication.
Two fractionation modalities (number of sessions) are considered as therapeutic standards, conventional fractionation (39 to 40 sessions of 2 Gy in 8 weeks) and moderate hypo-fractionation (20 sessions of 3 Gy). More recently, phase II and two phase III studies have shown equivalence in terms of safety and efficacy of "extreme hypofractionation" (5 or 6 sessions) for these localized cancers, using stereotactic-type techniques. In view of the current data, this fractionation is considered a therapeutic standard in some countries (notably the USA) and an option in France.
Delivering higher doses, beyond 80 GyEQD2 would improve tumor control, as demonstrated by randomized studies using brachytherapy, but at the cost of an increased risk of urinary toxicity.
As an alternative to this combination of external radiotherapy and brachytherapy, an innovative approach of external radiotherapy has been developed to increase the therapeutic ratio of patients with localized prostate cancer, based on an escalation of the radiation dose (> 95 GyEQD2) focused on the macroscopic tumor or "dominant intra-prostatic lesion" (DIPL), the area most at risk of local recurrence after conventional dose radiotherapy (3). This external radiotherapy technique consists in performing a conventional dose irradiation on the whole prostate, with at the same time (at each session) a higher dose ("Boost") on the DIPL. This is a modality known as "simultaneous integrated boost" (SIB).
The feasibility of simultaneous integrated boost (SIB) on the DIPL has been proven in external radiotherapy using conventional fractionation in the phase III FLAME study and the results in terms of long-term tumor control of this study showed a benefit in terms of biological recurrence-free survival.
Feasibility in terms of tolerance has also been established for very hypofractionated regimens (5 sessions), in particular in the HypoFLAME study that followed the above-mentioned study .
Multiparametric MRI (mpMRI) is used to identify and delineate the "dominant intra-prostatic lesion" (DIPL), and is the most commonly used modality in clinical studies that have evaluated SIB techniques.
However, several studies show that PET imaging, particularly 68Ga-PSMA PET, significantly improves the correlation between the image-defined DIPL and histological data and may improve the likelihood of tumor control. A dosimetric simulation study also showed that dose escalation based on 68Ga-PSMA PET could improve local tumor control with an acceptable level of toxicity .
Moreover, 68Ga-PSMA PET could be used to select the patients who could benefit most from this dose escalation, by excluding patients with lymph node or distant metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Integrated boostStereotactic radiotherapy in 5 fractions (on alternate day) * Whole prostate: 36.25 Gy - 7.25Gy/fraction * GTV-RT (boost): target 50 Gy - 10 Gy/fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient whose age is ≥ 18 years;
- Patient with intermediate-risk or high-risk prostate adenocarcinoma with a single severity criterion based on the NCCN classification
- Patient with at least 12 randomized biopsies
- N0 staging (CT or MRI or PET - choline) M0 (bone scan or PET - choline) with imaging workup less than 6 months old
- Dominant intra-prostate lesion identifiable on a recent multi-parametric MRI (< = 6 months) with an estimated volume < 40% of the entire prostate volume
Key exclusion criteria (15 listed)
- Patient with pre-therapeutic micturition disorders (IPSS score > 15)
- Patient with digestive inflammatory disease
- Patient with high risk prostate adenocarcinoma with more than one severity criteria based on the NCCN classification
- Prostate volume > 60 cc
- Patient with hip replacement
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 |
|---|---|---|
| Integrated boostIntegrated boost based on the dominant intra-prostatic lesion delineated on multi-parametric Magnetic Resonance Imaging and 68Ga-Prostate Specific Membrane Antigen Positron Emission Tomography | Radiation | Radiotherapy |
Primary outcome
Tolerance of the treatment regimen
Time frame: 12 Months
Rate of patients with at least one acute toxicity ≥ grade 3 occurring up to 3 months post RT or one late toxicity ≥ grade 2 occurring from 3 months post RT according to the NCI-CTC-v5.0 scale and attributable to radiotherapy (Gastrointestinal or genitourinary toxicities)
5 secondary outcomes
Change in the stage of the disease
Time frame: 5-10 days after trustee implantation
Dosimetric feasibility
Time frame: During RT
Adaptability of the 68Ga-PSMA PET preparation protocol to dosimetric planning
Time frame: Before RT
All grades toxicity
Time frame: 12 Months
Tumour control
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated boost in people with Prostate Adenocarcinoma, run by Centre Leon Berard at 4 sites in France.
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 7 inclusion and 15 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 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Séverine METZGER (04 78 78 27 86, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of the treatment regimen (time frame: 12 Months). 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 31 Oct 2022.