Prostate CancerPSMANCT03927521
Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study
A study testing Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance in people with Prostate Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
A significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2020to 11 Mar 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14.
- Biological recurrence after prostate radiotherapy confirmed with de Phoenix criteria (nadir + 2 ng/mL).
- No prior or present evidence of lymph node metastasis, soft tissue metastasis or bone metastasis, assessed by the current radiographic exam (PET-Choline) AND the PET-MRI/68Ga-PSMA before Focal-HIFU.
- Local prostate cancer recurrence confirmed by:
- A multiparametric MRI showing a single tumor in the prostate gland at most 3 contiguous sextants confirmed by biopsies (Index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by biopsies.
- Index tumor confirmed by the PET-MRI/68Ga-PSMA.
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- PSA ≤ 10ng/ml.
- Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- Patient affiliated with health insurance or beneficiary of an equivalent plan.
Who cannot join
- Contraindications to Focal-HIFU treatment.
- Patient with a medical contraindication to Sonovue® injection.
- Patient with a medical contraindication to MRI.
- History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
- History of sclerosis of the bladder neck or urethral stenosis.
- Patient at risk of bleeding according to medical advice. Patient with anticoagulants therapy must receive a treatment relay.
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- Patients with unstable neurological pathology.
- Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
- Legal person protected by law.
- Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon
Lyon, 69437
About this study
A significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of long-term recovery.
The use of Focused Ultrasound (HIFU) in focal treatment (only on recurrence) is an effective and not very morbid option, especially compared to surgery. The quality of this treatment is conditioned by both an early diagnosis of recurrence, a precise localization of recurrence in the prostate and a rigorous extension assessment for the detection of occult metastases.
Read more
Innovations in medical imaging have led to the development of a new generation of "hybrid" machines that combine PET (Positron Emission Tomodensitometry) and MRI (Magnetic Resonance Imaging) technology. Associated with the use of 68Gallium-labeled PSMA (Prostate-Specific Membrane Antigen), a new tracer specific for prostate cancer, the investigators believe that this PET-MRI imaging technique can:
- To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management.
- A better evaluation of the limits of local recurrence and therefore a more precise definition than with MRI alone of the tumor zone to be destroyed.
Finally, the investigators believe that the PET-MRI / 68Ga-PSMA exam, used for the selection of patients eligible for focal HIFU treatment and used for the treatment itself, should allow obtaining an optimal control of the cancer recurrence with the least possible side effects.
- Conditions
- Prostate Cancer
- Being tested
- Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance
- Keywords
- Prostate cancer, Post-Radiotherapy, Focal HIFU, PSMA, PET-MRI, Local recurrence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal HIFU using PET-MRI/68Ga-PSMA imaging guidanceProcedure or surgery
Focal HIFU treatment will be conducted with the Focal One® device using the PET-MRI/68Ga-PSMA imaging. The treatment area will be defined using PET-MRI/68Ga-PSMA imaging data and 3D biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Focal HIFU guided by PET-MRI/68Ga-PSMA imaging | Experimental | Patient with local/focal prostate cancer recurrence after radiotherapy and no distant metastasis (negative PET-Choline imaging confirmed by PET-MRI/68Ga-PSMA) will be treated by Focal-HIFU Receives: Procedure: Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance
The feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance will be evaluated by the possibility or not to use the target tumor contouring with the TEP-IRM au [68Ga]PSMA. This possibility will be determine for each patient with a systematic reviewing of TEP-IRM/[68Ga]PSMA and the target tumor contouring by 2 experts: a nuclear medicine specialist for TEP/[68Ga] PSMA and a radiologist, prostate MRI specialized.
Measured: At the time of the HIFU-focal treatment
Secondary outcomes (16)
Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to PET-Choline for the metastasis detection during the initial assessment of first recurrence after radiotherapy.
Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to PET-Choline for the metastasis detection during the initial assessment for first recurrence after radiotherapy will be evaluated by the proportion of patient who could not be treated by Focal-HIFU because of evidence of metastasis after the first PET-MRI/[68Ga]PSMA (screening failure rate).
Measured: Screening period.
Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to standard multiparametric MRI performed at the initial assessment AND 6 month after Focal-HIFU.
Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to standard multiparametric MRI will be evaluated by tumor volume comparison between both imaging method at the initial assessment AND 6 months after Focal-HIFU
Measured: 6 months after focal HIFU therapy
Biological recurrence
Biological recurrence will be evaluated by the proportion of biological recurrence, defined by a PSA nadir increase of more than 2 ng/mL at 3 and 6 months after Focal-HIFU.
Measured: 3 months and 6 months after focal HIFU therapy
Local control of tumor recurrence 6 months after Focal-HIFU guided by PET-MRI/[68Ga]PSMA imaging.
Local control of tumor recurrence 6 months after Focal-HIFU guided by PET-MRI/[68Ga]PSMA imaging will be evaluated by a second imaging assessment by PET-MRI/[68Ga]PSMA à 6 months after Focal-HIFU. In case of PSMA fixation on this imaging assessment, prostate biopsies will be performed.
Measured: 6 months after focal HIFU therapy
Proportion of positives prostate biopsies
Carcinologic evolution will be evaluated according to usual assessment performed for biological recurrence with proportion of positives prostate biopsies in the treated lobe and/or in the non-treated lobe.
Measured: 3 months and 6 months after focal HIFU therapy
Gleason score
Carcinologic evolution will be evaluated according to usual assessment performed for biological recurrence with evolution of the Gleason score (4+3 = 7 or ≥ 8).
Measured: 3 months and 6 months after focal HIFU therapy
Extracapsular extension of prostate cancer.
Carcinologic evolution will be evaluated according to usual assessment performed for biological recurrence with extracapsular extension of prostate cancer.
Measured: 3 months and 6 months after focal HIFU therapy
Metastatic free survival
The metastatic free survival will be measured from the inclusion date to the date of first metastasis confirmation
Measured: Over the 6 months after focal HIFU therapy
QLQC30 score (Quality of life questionnaire)
Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire. It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the better the quality of life.
Measured: 3 months and 6 months after focal HIFU therapy
EPIC-26 score (Urinary function questionnaire)
Urinary function will be assessed using the EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. The EPIC-26 is a self-reported scale health-related quality of life questionnaire for prostate cancer patients. It is composed of 26 items in 4 different domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal.
Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale. Each items as a standardized value from 0 to 100. Then the average of the standardized value is determined in each domain to crate the summary score. The higher the score, the better the quality of life.
Measured: 3 months and 6 months after focal HIFU therapy
IPSS score (Urinary function questionnaire)
Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire. The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.
Measured: 3 months and 6 months after focal HIFU therapy
IIEF-5 score (Sexual function questionnaire)
Sexual function will be assessed using will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire.The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high).
The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.
Measured: 3 months and 6 months after focal HIFU therapy
Adverse event evaluation
Adverse events assessment between patient inclusion to the last study visit at 6 months (+/- 30 days) after Focal-HIFU treatment
Measured: During 6 months of follow-up after focal HIFU therapy
Ancillary study: Measure of anti-tumoral immunity induction
The consequences of HIFU treatment over immune anti-tumoral induction will be estimated by the description of Programmed death-ligand 1/ligand 2 (PDL1/L2) overexpression on immune cells and overexpression of Programmed cell death 1 (PD-1) on T lymphocytes (T-cells).
Measured: Over the 6 months
Circulating Tumor Cells (CTC) number
The consequences of HIFU treatment over Messenger RNA (mRNA) will be estimated by measure of CTC number reduction (ancillary study).
Measured: Over the 6 months
ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level
The consequences of HIFU treatment over PCA3 will be estimated by measure of ncRNA PCA3 level reduction (ancillary study).
Measured: Over the 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start23 Jun 2020
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
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 Hospices Civils de LyonThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927521
- Sponsor's protocol ID
- 69HCL18_0536
- Acronym
- PSMA
- Status last verified
- May 2024
- First submitted
- 17 Apr 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Use of PET-MRI / 68Ga-PSMA Imaging for HIFU-focal Treatment in the Event of Recurrent Prostate Cancer After Radiotherapy - PSMA Study
- ClinicalTrials.gov ID
- NCT03927521
- Acronym / sponsor ID
- PSMA / 69HCL18_0536
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Post-Radiotherapy, Focal HIFU, PSMA, PET-MRI, Local recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 25 Apr 2019 (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 significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of long-term recovery.
The use of Focused Ultrasound (HIFU) in focal treatment (only on recurrence) is an effective and not very morbid option, especially compared to surgery. The quality of this treatment is conditioned by both an early diagnosis of recurrence, a precise localization of recurrence in the prostate and a rigorous extension assessment for the detection of occult metastases.
Innovations in medical imaging have led to the development of a new generation of "hybrid" machines that combine PET (Positron Emission Tomodensitometry) and MRI (Magnetic Resonance Imaging) technology. Associated with the use of 68Gallium-labeled PSMA (Prostate-Specific Membrane Antigen), a new tracer specific for prostate cancer, the investigators believe that this PET-MRI imaging technique can:
- To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management.
- A better evaluation of the limits of local recurrence and therefore a more precise definition than with MRI alone of the tumor zone to be destroyed.
Finally, the investigators believe that the PET-MRI / 68Ga-PSMA exam, used for the selection of patients eligible for focal HIFU treatment and used for the treatment itself, should allow obtaining an optimal control of the cancer recurrence with the least possible side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal HIFU guided by PET-MRI/68Ga-PSMA imaging | Experimental | Procedure: Focal HIFU using PET-MRI/68Ga-PSMA imaging guidancePatient with local/focal prostate cancer recurrence after radiotherapy and no distant metastasis (negative PET-Choline imaging confirmed by PET-MRI/68Ga-PSMA) will be treated by Focal-HIFU |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 50 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score > 14.
- Biological recurrence after prostate radiotherapy confirmed with de Phoenix criteria (nadir + 2 ng/mL).
- No prior or present evidence of lymph node metastasis, soft tissue metastasis or bone metastasis, assessed by the current radiographic exam (PET-Choline) AND the PET-MRI/68Ga-PSMA before Focal-HIFU.
- Local prostate cancer recurrence confirmed by:
- PSA ≤ 10ng/ml.
Key exclusion criteria (10 listed)
- Contraindications to Focal-HIFU treatment.
- Patient with a medical contraindication to Sonovue® injection.
- Patient with a medical contraindication to MRI.
- History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
- History of sclerosis of the bladder neck or urethral stenosis.
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 |
|---|---|---|
| Focal HIFU using PET-MRI/68Ga-PSMA imaging guidanceFocal HIFU treatment will be conducted with the Focal One® device using the PET-MRI/68Ga-PSMA imaging. The treatment area will be defined using PET-MRI/68Ga-PSMA imaging data and 3D biopsies. | Procedure or surgery | Focal HIFU guided by PET-MRI/68Ga-PSMA imaging |
Primary outcome
Feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance
Time frame: At the time of the HIFU-focal treatment
The feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance will be evaluated by the possibility or not to use the target tumor contouring with the TEP-IRM au [68Ga]PSMA. This possibility will be determine for each patient with a systematic reviewing of TEP-IRM/[68Ga]PSMA and the target tumor contouring by 2 experts: a nuclear medicine specialist for TEP/[68Ga] PSMA and a radiologist, prostate MRI specialized.
16 secondary outcomes
Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to PET-Choline for the metastasis detection during the initial assessment of first recurrence after radiotherapy.
Time frame: Screening period.
Interest of hybrid PET-MRI/[68Ga]PSMA imaging compared to standard multiparametric MRI performed at the initial assessment AND 6 month after Focal-HIFU.
Time frame: 6 months after focal HIFU therapy
Biological recurrence
Time frame: 3 months and 6 months after focal HIFU therapy
Local control of tumor recurrence 6 months after Focal-HIFU guided by PET-MRI/[68Ga]PSMA imaging.
Time frame: 6 months after focal HIFU therapy
Proportion of positives prostate biopsies
Time frame: 3 months and 6 months after focal HIFU therapy
Gleason score
Time frame: 3 months and 6 months after focal HIFU therapy
Extracapsular extension of prostate cancer.
Time frame: 3 months and 6 months after focal HIFU therapy
Metastatic free survival
Time frame: Over the 6 months after focal HIFU therapy
QLQC30 score (Quality of life questionnaire)
Time frame: 3 months and 6 months after focal HIFU therapy
EPIC-26 score (Urinary function questionnaire)
Time frame: 3 months and 6 months after focal HIFU therapy
IPSS score (Urinary function questionnaire)
Time frame: 3 months and 6 months after focal HIFU therapy
IIEF-5 score (Sexual function questionnaire)
Time frame: 3 months and 6 months after focal HIFU therapy
Adverse event evaluation
Time frame: During 6 months of follow-up after focal HIFU therapy
Ancillary study: Measure of anti-tumoral immunity induction
Time frame: Over the 6 months
Circulating Tumor Cells (CTC) number
Time frame: Over the 6 months
ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level
Time frame: Over the 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- RHU Perfuse web siteLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance in people with Prostate Cancer, run by Hospices Civils de Lyon at 1 site 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 8 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to use the PET-MRI/68Ga-PSMA imaging for Focal-HIFU guidance (time frame: At the time of the HIFU-focal 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 8 May 2024.