Prostate Cancer Clinical Trial
— IRMProftOfficial title:
Performance of Prostate MRI and Targeted Biopsy to Detect Residual Prostate Cancer Following Focal Therapy
The management of localized prostate cancer remains controversial because of a risk of over diagnosis and over treatment. Focal therapy represents an approach to improve the therapeutic ratio of prostate cancer treatments. Focal therapy has been developed as minimally invasive procedure with the aim of providing equivalent oncological safety, reduced toxicity and improved functional outcomes. Multiparametric (mp) MRI Imaging may provide a reliable mean of monitoring for disease recurrence, and has been suggested as the most accurate imaging tool currently available for systematic detection of recurrence, pre-biopsy and preoperative mapping for an eventual salvage therapy. However, question about the performance of MRI and targeted biopsy in monitoring and defining successful therapy and follow up has been poorly evaluated. Modalities (standard biopsy, ablation zone biopsy vs targeted biopsy) and number of biopsies to be performed, depending on the results of MRI, remains unanswered due to a lack of available data. We hypothesize that the combination of MpMRI of the prostate with subsequent targeted biopsy (TB) may improve detection of prostate cancer and may therefore improve the follow-up of men after focal therapy (FT) to better identify patients that need a salvage treatment and when.
Status | Recruiting |
Enrollment | 260 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion criteria 1. Age > 18 years 2. Detection of prostate cancer must have be done by combination of MRI plus biopsy following (EAU guidelines and French Guidelines) 3. Patient had no prior treatment for PCa 4. The patient could be classified as low- or intermediate-risk, according to D'Amico's 2003 [15] risk group categories: T1c, T2a, PSA less than 20ng/ml, with Gleason Grade of 6 (3+3) or 7 (3+4 ) (ISUP 1 and ISUP 2) 5. Management decisions should be made after all treatments have been discussed in a multidisciplinary team and after the balance of benefits and side-effects of appropriate therapy modalities has been considered together with the patient. 6. Patient informed of treatment options and have already chosen to undergo focal treatment (focal, quadrant or hemi-ablation) by cryotherapy, high-intensity focused ultrasound (HIFU), irreversible electroporation, laser ablation therapy (including photodynamic therapy) and microwave 7. Preoperative MRI and biopsy results will be mandatory 8. Participant must be willing to attend the follow up visits 9. Participant must be willing and able to attend follow-up MRI and prostate biopsies 10. Written informed consent 11. Affiliation to a French social security system excluding AME (Aide médicale d'état) Exclusion criteria 1. Hormone therapy within the past year 2. Prior pelvic radiotherapy 3. Focal brachytherapy 4. Concurrent participation in other interventional clinical studies with radical treatment of prostate cancer 5. Contraindications to undergo MpMRI or Trans rectal ultrasound TRUS-guided prostate biopsy (TRUS-Bx) 6. Patient deprived of liberty or under legal protection measure |
Country | Name | City | State |
---|---|---|---|
France | CHRU Brest - Hôpital de la Cavale Blanche | Brest | |
France | CH Chartres - Hôpital Louis Pasteur | Chartres | |
France | CHU DIJON Francois Mitterrand | Dijon | |
France | CHU de Nice Hôpital Pasteur 2 | Nice | |
France | Groupe Hospitalier Pitié Salpêtrière | Paris | |
France | Hôpital Cochin | Paris | |
France | Hôpital Tenon | Paris | |
France | Institut Mutualiste Montsouris | Paris | |
France | Clinique La Croix du Sud Quint-Fonsegrives | Quint-Fonsegrives | |
France | CHU de Rennes - Hôpital Pontchaillou | Rennes | |
France | Hôpital Foch | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The detection rate of prostate cancer after focal treatment | To compare the detection rates obtained by both standard (STB) and targeted methods (TB), both types of biopsy being done on the same subjects | At 12 months after focal treatment | |
Secondary | PCa detection on the combination of Targeted Biopsy (TB) and Non targeted Biopsy (NTB) | To estimate the detection of Pca by the combination of the TB and NTB at once, and determinate the sensibility and the specificity in this configuration of combination. | At 12 months after focal treatment | |
Secondary | Morbidity of prostate biopsy | Nature and severity of short term and long term biopsy complications: infection, hemorrhage, other | through the study completion, an average of 40 months | |
Secondary | Number of salvage treatment by focal therapy | through the study completion, an average of 40 months | ||
Secondary | Number of salvage treatment by radical prostatectomy | through the study completion, an average of 40 months | ||
Secondary | Number of salvage treatment by external radiotherapy | through the study completion, an average of 40 months | ||
Secondary | Prostate Specific Antigen (PSA) | at 3 months, 6 months,12 months | ||
Secondary | Prostate Specific Antigen density (PSAd) | at 3 months and 12 months | ||
Secondary | Accuracy of MpMRI to detect PCa after focal treatment | At 12 month after focal treatment | ||
Secondary | Number of positive MpMRI | Number of positive MpMRI define by a Likert score > =3 in the treated and the non-treated zone | through the study completion, an average of 40 months | |
Secondary | Localization of positive MpMRI | Localization of positive Mp MRI define by a Likert score > =3 in the treated and the non-treated zone | through the study completion, an average of 40 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |