Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01915-48 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The authors hypothesize that, in patients with low volume tumors identified according to anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by unilateral embolization of prostatic arteries will provide local control of the tumor via selective ischemia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate cancer patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization | Procedure | Embolization by microparticles (300-500 microns) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications arising from embolization | Presence/absence of complications beyond those expected linked to embolization (persistent urinary infection, dysuria, rectorrhagia, hematuria, hemospermia, acute urinary retention and pelvic perineal pain) | Month 6 |
| Presence of cancerous cells | Positive/negative according to biopsy of treated lobe | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Global survival | days | Month 6 |
| Use of other mode of treatment | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julian Frandon, MD | CHU Nimes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33248919 | Result | Frandon J, Bey E, Hamard A, Mohammad H, Gonzalez S, Greffier J, Chevallier T, de Forges H, Beregi JP, Droupy S. Early Results of Unilateral Prostatic Artery Embolization as a Focal Therapy in Patients with Prostate Cancer under Active Surveillance: Cancer Prostate Embolisation, a Pilot Study. J Vasc Interv Radiol. 2021 Feb;32(2):247-255. doi: 10.1016/j.jvir.2020.10.002. Epub 2020 Nov 25. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Month 1 |
| Use of other mode of treatment | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) | Month 3 |
| Use of other mode of treatment | Yes/No of radical treatment (surgery, radiotherapy, high intensity focused ultrasound) | Month 6 |
| Necrosis of treated lobe | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Day 0 |
| Necrosis of treated lobe | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Week 2 |
| Necrosis of treated lobe | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Month 6 |
| Change in size of target | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Day 0 |
| Change in size of target | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Week 2 |
| Change in size of target | MRI analysis (Pi RADS VS and RECIST 1.1 if lesion >10mm) | Month 6 |
| Prostate specific antigen level | ng/ml | Month 1 |
| Prostate specific antigen level | ng/ml | Month 3 |
| Prostate specific antigen level | ng/ml | Month 6 |
| Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification | Expected events: severe allergic reaction to contrast product, septicemia with urinary origin, persistent urinary infection, dysuria, serious hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectorrhagia, irradiation-induced severe epidermal lesions, acute urinary retention, pelvic-perineal pain, prostatitis, epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder, elevation of PSA (at 6 months linked to probable disease progression). | Month 1 |
| Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification | Expected events: severe allergic reaction to contrast product, septicemia with urinary origin, persistent urinary infection, dysuria, serious hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectorrhagia, irradiation-induced severe epidermal lesions, acute urinary retention, pelvic-perineal pain, prostatitis, epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder, elevation of PSA (at 6 months linked to probable disease progression). | Month 3 |
| Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification | Expected events: severe allergic reaction to contrast product, septicemia with urinary origin, persistent urinary infection, dysuria, serious hematuria, hemospermia, bladder ulceration/necrosis, rectal ulcer, rectorrhagia, irradiation-induced severe epidermal lesions, acute urinary retention, pelvic-perineal pain, prostatitis, epididymitis, obstructive renal failure, chronic bladder retention, lithiasis, hypocontractile bladder, elevation of PSA (at 6 months linked to probable disease progression). | Month 6 |
| Urinary symptoms | International Prostate Symptom Score (IPSS score) (0-35) | Month 1 |
| Urinary symptoms | International Prostate Symptom Score (IPSS score) (0-35) | Month 3 |
| Urinary symptoms | International Prostate Symptom Score (IPSS score) (0-35) | Month 6 |
| Incontinence | 24-hr pad test (g) | Month 1 |
| Incontinence | 24-hr pad test (g) | Month 3 |
| Incontinence | 24-hr pad test (g) | Month 6 |
| Erectile dysfunction | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) | Month 1 |
| Erectile dysfunction | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) | Month 3 |
| Erectile dysfunction | International Index of Erectile Function (IIEF-6) questionnaire (score 0-30) | Month 6 |
| Health-related quality of life | euroqol 5 dimension questionnaire (EQ-5D) | Month 1 |
| Health-related quality of life | euroqol 5 dimension questionnaire (EQ-5D) | Month 3 |
| Health-related quality of life | euroqol 5 dimension questionnaire (EQ-5D) | Month 6 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
Not provided
Not provided