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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) (Prostate-SIB)

Primary Purpose

Prostate Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Integrated boost
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Localized, Intermediate risk, Initial care, Not operated, Integrated boost, multiparametric MRI, Dominant Intra-Prostatic Lesion (DIPL), 68Ga-PSMA PET, Safety, Dosimetric planning, Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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) 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.

Sites / Locations

  • Centre Marie Curie
  • CAC-Clermont-Ferrand - Centre Jean Perrin
  • Hospices Civils de Lyon (Hôpital Edouard Herriot)
  • Centre Léon BérardRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Dosimetric feasibility
Dose delivered on DIPL and proportion of patients for whom dose escalation ≥ 95 GyEQD2 is possible
Adaptability of the 68Ga-PSMA PET preparation protocol to dosimetric planning
Confirmation that the 68Ga-PSMA PET preparation protocol is suitable for dosimetric planning
All grades toxicity
Rate of all grades of toxicity according to NCI-CTC-v5.0
Tumour control
Rate of patients with recurrence (biological, local or distant)

Full Information

First Posted
October 26, 2022
Last Updated
October 26, 2022
Sponsor
Centre Leon Berard
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1. Study Identification

Unique Protocol Identification Number
NCT05599737
Brief 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)
Acronym
Prostate-SIB
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
May 25, 2024 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Localized, Intermediate risk, Initial care, Not operated, Integrated boost, multiparametric MRI, Dominant Intra-Prostatic Lesion (DIPL), 68Ga-PSMA PET, Safety, Dosimetric planning, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Integrated boost
Intervention Description
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
Primary Outcome Measure Information:
Title
Tolerance of the treatment regimen
Description
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)
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Change in the stage of the disease
Description
Proportion of patients excluded following 68Ga-PSMA PET (non-localised cancers or Index Tumour > 40% of prostate volume)
Time Frame
5-10 days after trustee implantation
Title
Dosimetric feasibility
Description
Dose delivered on DIPL and proportion of patients for whom dose escalation ≥ 95 GyEQD2 is possible
Time Frame
During RT
Title
Adaptability of the 68Ga-PSMA PET preparation protocol to dosimetric planning
Description
Confirmation that the 68Ga-PSMA PET preparation protocol is suitable for dosimetric planning
Time Frame
Before RT
Title
All grades toxicity
Description
Rate of all grades of toxicity according to NCI-CTC-v5.0
Time Frame
12 Months
Title
Tumour control
Description
Rate of patients with recurrence (biological, local or distant)
Time Frame
12 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Séverine METZGER
Phone
04 78 78 27 86
Email
severine.metzger@lyon.unicancer.fr
Facility Information:
Facility Name
Centre Marie Curie
City
Valence
State/Province
Drôme
ZIP/Postal Code
26000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste GUY, MD, PhD
Phone
04 75 81 33 81
Email
dr.guy@cmc-valence.org
Facility Name
CAC-Clermont-Ferrand - Centre Jean Perrin
City
Clermont-Ferrand
State/Province
Puy-de-Dôme
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent GUILLEMIN, MD
Phone
04 73 27 80 80
Email
florent.GUILLEMIN@clermont.unicancer.fr
Facility Name
Hospices Civils de Lyon (Hôpital Edouard Herriot)
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier ROUVIERE, MD, PhD
Email
olivier.rouviere@chu-lyon.fr
Facility Name
Centre Léon Bérard
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal POMMIER, MD
Phone
04 78 78 51 66
Email
pascal.pommier@lyon.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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)

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