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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001920-36 | EudraCT Number | ||
| 2019-A02946-51 | Registry Identifier | RCB No. |
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Recruitment difficulties
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Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy.
The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.
The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing transarterial embolization of the prostate | Experimental | Three patients will undergo transarterial embolization of the prostate using unloaded beads. |
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| Transarterial prostatic chemoembolization, 2.5 mg doxorubicin | Experimental | Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 2.5 mg of doxorubicin. |
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| Transarterial prostatic chemoembolization, 5.0 mg doxorubicin | Experimental | Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 5.0 mg of doxorubicin. |
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| Transarterial prostatic chemoembolization, 10.0 mg doxorubicin | Experimental | Three patients will undergo transarterial chemoembolization of the prostate using beads loaded with 10.0 mg of doxorubicin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of embolization beads | Other | Patients will receive embolization beads, loaded with doxorubicin or not. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety of prostate embolization using unloaded beads. | The number of serious undesirable events will be noted during the embolization. The undesirable event noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 0 (i.e. on the day of the intervention) |
| Evaluation of safety of prostate embolization using unloaded beads. | The number of serious undesirable events will be noted the day after embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 1 (i.e. one day after the intervention) |
| Evaluation of safety of prostate embolization using unloaded beads. | The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 5 (i.e. 5 days after the intervention) |
| Evaluation of safety of prostate embolization using unloaded beads. | This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 14 (i.e. 2 weeks after the intervention) |
| Evaluation of safety of prostate embolization using unloaded beads. | Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 30 (i.e. 1 month after the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of prostate embolization using unloaded beads. | Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin. |
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Inclusion Criteria:
Exclusion Criteria:
As the study relates to embolization of prostate cancer, only male patients are concerned.
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| Name | Affiliation | Role |
|---|---|---|
| Anissa MEGZARI | CHU de Nîmes, Place du Professeur Debré, 30029 Nîmes Cedex | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nîmes University Hospital | Nîmes | Gard | 30029 | France |
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This is a purely descriptive, non randomized, non controlled, prospective sequential-type pilot study on the first use in the indication for prostatic arterial embolization using beads loaded with doxorubicin in increasing doses: 0 mg, 2.5mg, 5 mg and 10 mg. It is a study with escalating doses of doxorubicin : 3 patients with non-loaded beads, 3 patients with beads loaded at 2.5 mg (1/20 of the dose administered for liver tumors), 3 patients with beads loaded at 5mg and 3 patients with beads loaded at 10mg.
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| Evaluation of safety of prostate embolization using unloaded beads. | Evaluation of post-operative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Three months after the intervention |
| Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin | The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 0 (i.e. on the day of the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin | The number of serious undesirable events will be noted after the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 1 (i.e. one day after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin | The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 5 (i.e. 5 days after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin | This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula or abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 14 (i.e. 2 weeks after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin | Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 30 (i.e. 1 month after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 2.5 mg of doxorubicin | Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Three months after the intervention |
| Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin | The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 0 (i.e. on the day of the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin | The number of serious undesirable events will be noted after the embolization. The side effects noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 1 (i.e. one day after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin | The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 5 (i.e. 5 days after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin | This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 14 (i.e. 2 weeks after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin | Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 30 (i.e. 1 month after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 5.0 mg of doxorubicin | Postoperative complications. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | 3 months after the intervention |
| Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin | The number of serious undesirable events will be noted during the embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 0 (i.e. on the day of the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin | The number of serious undesirable events will be noted after the clinical embolization. The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 1 (i.e. one day after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin | The number of serious undesirable events will be noted by telephone. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 5 (i.e. 5 days after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin | This will be evaluated by magnetic resonance imaging (vesicular or rectal necrosis, fistula, abcess) and at the time of surgery.The undesirable events noted will be: non-targeted necrosis, intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 14 (i.e. 2 weeks after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin | Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Day 30 (i.e. 1 month after the intervention) |
| Evaluation of safety of prostate embolization using beads loaded with 10.0 mg of doxorubicin | Postoperative complications. The undesirable events noted will be: intense vesicle or rectal pain, rectal bleeding, abundant hematuria and fever. | Three months after the intervention |
Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area. |
| Day 14 |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin. | Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin. | Dynamic contrast-enhanced Magnetic Resonance Imaging (1.5 or 3 Tesla multiparametric acquisition with T2 morphologic sequencing) will be performed to evaluate modifications in tumor volume and necrosis area. | Day 14 |
| Tolerance of prostate embolization using unloaded beads: Clavien-Dindo score | Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess… | Day 14 |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin:Clavien-Dindo score | Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess… | Day 14 |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: Clavien-Dindo score | Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess… | Day 14 |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: Clavien-Dindo score | Postoperative complications evaluated according to the Clavien-Dindo score: bruising, arterial wound with bleeding, vesicle wound, rectal wound, parietal abcess, deep abcess… | Day 14 |
| Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 14 |
| Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 30 (i.e. one month after embolization) |
| Tolerance of prostate embolization using unloaded beads : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Three months after embolization |
| Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 14 |
| Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 30 (i.e. 1 month after embolization) |
| Evaluation of tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 30 i.e. 1 month after embolization |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : International Prostate Symptom Score | The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. | Three months after embolization |
| Tolerance of prostate embolization using unloaded beads : IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 14 |
| Tolerance of prostate embolization using unloaded beads : IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using unloaded beads : IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 30 (i.e. one month after embolization) |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Three months after embolization) |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Day 30 (i.e.1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin: IIEF-6 score | The International Index of Erectile Function (IIEF-6 ) score was developed and validated in 96-97 by Pfizer then adopted by the WHO as the gold standard for judging the efficacy of treatment for erection difficulties evaluated as part of clinical trials. It is the most commonly-used validated, multidimensional, self-administered questionnaire to evaluate erection difficulties (Rosen, Althof & Giuliano 2006). It consists of 15 questions covering 5 areas: erectile function (questions 1, 2, 3, 4, 5 and 15),satisfaction regarding sexual activity (questions 6,7 and 8), orgasm (questions 9 and 10), sexual desire (questions 11 and 12), overall satisfaction (questions 13 and 14). Patients must respond to the questionnaire based on their own experience over the last 4 weeks. | Three months after embolization |
| Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 14 |
| Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using unloaded beads : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicin : EORTC - QLQ-C30 score | The European Organisation for Research and Treatment of Cancer (EORTC) developed the QLQ-C30 self-questionnaire to evaluate the patient's quality of life after the intervention. It contains 28 questions with 4 possibilities of answers each with 4 possibilities: 1 = Not at All 2 = A Little 3 = Quite a Bit 4 = Very Much and two questions each with a seven-point Lickert scale in which 1 = very poor and 7 = excellent relating respectively to how the patient would rate his general health in the past week and how he would rate his quality of life in the past week. | Three months after embolization |
| Tolerance of prostate embolization using unloaded beads : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 14 |
| Tolerance of prostate embolization using unloaded beads : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using unloaded beads : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 30 (1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 2.5 mg of doxorubicine : 24h pad-test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Three months after embolization) |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 30 (i.e. 1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 5.0 mg of doxorubicine : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Three months after embolization |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 14 |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Day 30 (1 month after embolization) |
| Tolerance of prostate embolization using beads loaded with 10.0 mg of doxorubicine : 24h pad test | The 24h pad-test, or incontinence test, is a way of objectively, qualitatively and quantitatively measuring urine leakage under trial conditions. The time limit is 24 hours. The weight of dry pads is compared with the weight of all wet pads after 24 hours. | Three months after embolization |
| Prostate-specific antigen level in patients treated with unloaded beads. | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 14 before surgery |
| Prostate-specific antigen level in patients treated with unloaded beads. | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 30 (i.e. 1 month after embolization) |
| Prostate-specific antigen level in patients treated with unloaded beads. | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Three months after embolization |
| Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 14 before surgery |
| Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 30 (i.e. 1 month after embolization) |
| Prostate-specific antigen level in patients treated with beads loaded with 2.5 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Three months after embolization |
| Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 14 before surgery |
| Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 30 (i.e. month after embolization) |
| Prostate-specific antigen level in patients treated with beads loaded with 5.0 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Three months after embolization |
| Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 14 |
| Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Day 30 (i.e. 1 month after embolization) |
| Prostate-specific antigen level in patients treated with beads loaded with 10.0 mg of doxorubicine . | This test measures the amount of prostate-specific antigen (PSA) in the patient's blood. PSA is a protein produced by both cancerous and noncancerous tissue in the prostate. It is useful for the early detection of cancer. | Three months after embolization |
| Biological checkup for patients treated with beads loaded with 2.5 mg of doxorubicine | The following levels will be tested : uric acid, potassium, creatinin, calcium. phosphate) | Three months after embolization |
| Biological checkup for patients treated with beads loaded with 5.0 mg of doxorubicine | The following levels will be tested : uric acid, potassium, creatinin, calcium. | Three months after embolization |
| Biological checkup for patients treated with beads loaded with 10.0 mg of doxorubicine | The following levels will be tested : uric acid, potassium, creatinin, calcium. | Three months after embolization |
| Complete blood count for patients treated with beads loaded with 2.5 mg of doxorubicine | The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means. | Three months after embolization |
| Complete blood count for patients treated with beads loaded with 5.0 mg of doxorubicine | The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means. | Three months after embolization |
| Complete blood count for patients treated with beads loaded with 10.0 mg of doxorubicine | The volume of hemoglobine, red blood cells, white blood cells, neutrophils, granulocytes,lymphocytes, monocytes, eosinophils, basophils and platelets will be measured platelets according to the traditional means. | Three months after embolization |
| Liver test for patients treated with beads loaded with 2.5 mg of doxorubicine | The following elements will be measured and compared with the test results before treatment :
| Three months after embolization |
| Liver test for patients treated with beads loaded with 5.0 mg of doxorubicine | The following elements will be measured and compared with the test results before treatment :
| Three months after embolization |
| Liver test for patients treated with beads loaded with 10.0 mg of doxorubicine | The following elements will be measured and compared with the test results before treatment :
| Three months after embolization |
| Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 2.5 mg of doxorubicine | The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). | Three months after embolization |
| Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 5.0 mg of doxorubicine | The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). | Three months after embolization |
| Cardiac ultrasound and electrocardiogram for patients treated with beads loaded with 10.0 mg of doxorubicine | The left ventricular ejection fraction will be calculated by dividing the volume of blood pumped from the left ventricle per beat (stroke volume) by the volume of blood collected in the left ventricle at the end of diastolic filling (end-diastolic volume). | Three months after embolization |
| Systemic dosage of free doxorubicin in blood in patients treated with beads loaded with 2.5 mg of doxorubicine | A blood sample will be taken and the concentration of doxorubicin will be measured in mg/m2 | Day 1 |
| 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