ID

41149

Descripción

Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.; ODM derived from: https://clinicaltrials.gov/show/NCT01902680

Link

https://clinicaltrials.gov/show/NCT01902680

Palabras clave

Versiones (1)
  1. 1/7/20 1/7/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

1 de julio de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Localized Prostate Cancer NCT01902680

Inglés

Eligibility Localized Prostate Cancer NCT01902680

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men of more than 18 years old
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. patient with localized prostate cancer with a good prognosis (amico classification), ie satisfying the following conditions according to the urologist medical record transmitted:
Descripción

Malignant neoplasm of prostate Localized | Prognosis good

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0376358
UMLS CUI [1,2]
C0392752
UMLS CUI [2]
C0278250
lesion classified t1c or t2a based on digital rectal exam
Descripción

Lesion TNM clinical staging Digital Rectal Examination

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C1384593
histologically proven diagnosis of prostatic adenocarcinoma with a gleason score
Descripción

Adenocarcinoma of prostate Gleason score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3203027
serum prostatic specific antigen (psa) <10ng/ml
Descripción

Prostate specific antigen measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201544
3. patient for whom the multidisciplinary consultative meeting (rcp) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
Descripción

Surveillance | Brachytherapy | Radical prostatectomy | External Beam Radiation Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0733511
UMLS CUI [2]
C0006098
UMLS CUI [3]
C0194810
UMLS CUI [4]
C1517033
4. patient with good micturating function at inclusion, defined by ipss score <10 (ipss questionnaire)
Descripción

Normal micturition IPSS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2712184
UMLS CUI [1,2]
C1998280
5. patient for whom the result of centralized psa assay confirms a serum level < 10ng/ml
Descripción

Prostate specific antigen measurement | PSA - Prostate specific antigen level result

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2]
C0428540
6. patient for whom the unique and intracapsular character of the target area (area to be treated) was confirmed on pre implantation multimodal mri imaging (esur score ≥ 9) and whose major axis has a size ≤ 20 mm
Descripción

Target Area Multimodal Magnetic Resonance Imaging | Major Axis Size

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1513743
UMLS CUI [1,4]
C0024485
UMLS CUI [2,1]
C1295723
UMLS CUI [2,2]
C0456389
7. patient with a gleason score on the target ≤ 6 (3 +3) confirmed on biopsies performed using koelis ® system and with no other derogatory criteria such as the invasion of the entire core or the presence of a grade 4 or perineural emboli
Descripción

Target Gleason score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C3203027
8. patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
Descripción

Transurethral Resection Absent | Adenoma Obstructive Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519630
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0001430
UMLS CUI [2,2]
C0549186
UMLS CUI [2,3]
C0332197
9. patient who accepts, at the end of the study, the principle of active surveillance for the rest of the gland and the treated area according to the current standard protocol
Descripción

Surveillance Agreement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0733511
UMLS CUI [1,2]
C0680240
10. who ≤ 2
Descripción

WHO tumor classification

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1301142
11. patient with life expectancy > 10 years
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
12. informed consent obtained and signed before any specific procedure in the study
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
13. patient affiliated to social security regimen
Descripción

Social Security Affiliated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C1510826
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. image in favour of the crossing of the capsule, based on pre-implantation multimodal mri (stage t2 mri only)
Descripción

Capsule of prostate Diagnostic Imaging | Capsule of prostate Multimodal Magnetic Resonance Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0227963
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0227963
UMLS CUI [2,2]
C1513743
UMLS CUI [2,3]
C0024485
2. image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal mri (stage t2 mri only)
Descripción

Invasion Seminal Vesicles Diagnostic Imaging | Invasion Seminal Vesicles Multimodal Magnetic Resonance Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0036628
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C1269955
UMLS CUI [2,2]
C0036628
UMLS CUI [2,3]
C1513743
UMLS CUI [2,4]
C0024485
3. multifocal lesions (esur ≥ 9/15) to the pre-implantation multimodal mri and for which biopsies have shown the cancerous nature
Descripción

Multifocal Lesion Multimodal Magnetic Resonance Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1334819
UMLS CUI [1,2]
C1513743
UMLS CUI [1,3]
C0024485
4. lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal mri
Descripción

Lesion Diameter Multimodal Magnetic Resonance Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C1513743
UMLS CUI [1,4]
C0024485
5. patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
Descripción

Hormone Therapy Required | Reduction Prostate volume

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C0392756
UMLS CUI [2,2]
C1441416
6. patient with current indication against prostate brachytherapy, including a significant limitation of the mobility of the hips, a prostate volume greater than 60 cm3 (measured by planimetry mri) or a significant dysuria (ipss ≥ 10)
Descripción

Indication Against Brachytherapy to prostate | HIP MOBILITY LIMITED | Prostate volume MRI | Dysuria IPSS

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0854662
UMLS CUI [2]
C0744935
UMLS CUI [3,1]
C1441416
UMLS CUI [3,2]
C0024485
UMLS CUI [4,1]
C0013428
UMLS CUI [4,2]
C1998280
7. patient unable to follow procedures, visits, examinations described in the the study
Descripción

Protocol Compliance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
8. patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
Descripción

Indication Against Imaging Techniques | Claustrophobia | Heart Valve Prosthesis | Artificial cardiac pacemaker

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0079595
UMLS CUI [2]
C0008909
UMLS CUI [3]
C0018825
UMLS CUI [4]
C0030163
9. man of childbearing age who do not want follow the instructions about sexual activities and condom use during the days following the treatment of brachytherapy and / or unwilling to hold (him or her partner) effective contraception for the duration of the study
Descripción

Gender Fertility | Contraceptive methods Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0015895
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0558080
10. any concomitant or previous malignant disease in the past five years with the exception of superficial basal cell carcinoma or non-metastatic of the skin
Descripción

Malignant disease | Exception Superficial basal cell carcinoma | Exception Basal cell carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0442867
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0862889
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
11. any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
Descripción

Systemic Chemotherapy | Status pre- Malignant disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0442867
12. any coexisting medical condition that in the opinion of the investigator could be a risk in this study
Descripción

Medical condition At risk Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0008976
13. patient protected by law
Descripción

Patient rights protection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0150300
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Similar models

Eligibility Localized Prostate Cancer NCT01902680

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. men of more than 18 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Malignant neoplasm of prostate Localized | Prognosis good
Item
2. patient with localized prostate cancer with a good prognosis (amico classification), ie satisfying the following conditions according to the urologist medical record transmitted:
boolean
C0376358 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C0278250 (UMLS CUI [2])
Lesion TNM clinical staging Digital Rectal Examination
Item
lesion classified t1c or t2a based on digital rectal exam
boolean
C0221198 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1384593 (UMLS CUI [1,3])
Adenocarcinoma of prostate Gleason score
Item
histologically proven diagnosis of prostatic adenocarcinoma with a gleason score
boolean
C0007112 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
Prostate specific antigen measurement
Item
serum prostatic specific antigen (psa) <10ng/ml
boolean
C0201544 (UMLS CUI [1])
Surveillance | Brachytherapy | Radical prostatectomy | External Beam Radiation Therapy
Item
3. patient for whom the multidisciplinary consultative meeting (rcp) has adopted the following treatment options: active surveillance, brachytherapy, radical prostatectomy or external radiation
boolean
C0733511 (UMLS CUI [1])
C0006098 (UMLS CUI [2])
C0194810 (UMLS CUI [3])
C1517033 (UMLS CUI [4])
Normal micturition IPSS
Item
4. patient with good micturating function at inclusion, defined by ipss score <10 (ipss questionnaire)
boolean
C2712184 (UMLS CUI [1,1])
C1998280 (UMLS CUI [1,2])
Prostate specific antigen measurement | PSA - Prostate specific antigen level result
Item
5. patient for whom the result of centralized psa assay confirms a serum level < 10ng/ml
boolean
C0201544 (UMLS CUI [1])
C0428540 (UMLS CUI [2])
Target Area Multimodal Magnetic Resonance Imaging | Major Axis Size
Item
6. patient for whom the unique and intracapsular character of the target area (area to be treated) was confirmed on pre implantation multimodal mri imaging (esur score ≥ 9) and whose major axis has a size ≤ 20 mm
boolean
C1521840 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1513743 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C1295723 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Target Gleason score
Item
7. patient with a gleason score on the target ≤ 6 (3 +3) confirmed on biopsies performed using koelis ® system and with no other derogatory criteria such as the invasion of the entire core or the presence of a grade 4 or perineural emboli
boolean
C1521840 (UMLS CUI [1,1])
C3203027 (UMLS CUI [1,2])
Transurethral Resection Absent | Adenoma Obstructive Absent
Item
8. patients without history of transurethral resection that could have significantly modified the anatomy of the gland nor obstructive adenoma
boolean
C1519630 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0001430 (UMLS CUI [2,1])
C0549186 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Surveillance Agreement
Item
9. patient who accepts, at the end of the study, the principle of active surveillance for the rest of the gland and the treated area according to the current standard protocol
boolean
C0733511 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
WHO tumor classification
Item
10. who ≤ 2
boolean
C1301142 (UMLS CUI [1])
Life Expectancy
Item
11. patient with life expectancy > 10 years
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
12. informed consent obtained and signed before any specific procedure in the study
boolean
C0021430 (UMLS CUI [1])
Social Security Affiliated
Item
13. patient affiliated to social security regimen
boolean
C0037435 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Capsule of prostate Diagnostic Imaging | Capsule of prostate Multimodal Magnetic Resonance Imaging
Item
1. image in favour of the crossing of the capsule, based on pre-implantation multimodal mri (stage t2 mri only)
boolean
C0227963 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0227963 (UMLS CUI [2,1])
C1513743 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Invasion Seminal Vesicles Diagnostic Imaging | Invasion Seminal Vesicles Multimodal Magnetic Resonance Imaging
Item
2. image in favor of the invasion of the seminal vesicle, based on pre-implantation multimodal mri (stage t2 mri only)
boolean
C1269955 (UMLS CUI [1,1])
C0036628 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C1269955 (UMLS CUI [2,1])
C0036628 (UMLS CUI [2,2])
C1513743 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
Multifocal Lesion Multimodal Magnetic Resonance Imaging
Item
3. multifocal lesions (esur ≥ 9/15) to the pre-implantation multimodal mri and for which biopsies have shown the cancerous nature
boolean
C1334819 (UMLS CUI [1,1])
C1513743 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
Lesion Diameter Multimodal Magnetic Resonance Imaging
Item
4. lesion with larger diameter ≥ 20mm, to the pre-implantation multimodal mri
boolean
C0221198 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C1513743 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
Hormone Therapy Required | Reduction Prostate volume
Item
5. patient who requires pre-implantation hormonal treatment in order to reduce prostatic volume
boolean
C0279025 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0392756 (UMLS CUI [2,1])
C1441416 (UMLS CUI [2,2])
Indication Against Brachytherapy to prostate | HIP MOBILITY LIMITED | Prostate volume MRI | Dysuria IPSS
Item
6. patient with current indication against prostate brachytherapy, including a significant limitation of the mobility of the hips, a prostate volume greater than 60 cm3 (measured by planimetry mri) or a significant dysuria (ipss ≥ 10)
boolean
C3146298 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0854662 (UMLS CUI [1,3])
C0744935 (UMLS CUI [2])
C1441416 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0013428 (UMLS CUI [4,1])
C1998280 (UMLS CUI [4,2])
Protocol Compliance Unable
Item
7. patient unable to follow procedures, visits, examinations described in the the study
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Indication Against Imaging Techniques | Claustrophobia | Heart Valve Prosthesis | Artificial cardiac pacemaker
Item
8. patient with absolute indication against imaging tests (significant claustrophobia, wearing a heart valve, pacemaker, ..)
boolean
C3146298 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0079595 (UMLS CUI [1,3])
C0008909 (UMLS CUI [2])
C0018825 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
Gender Fertility | Contraceptive methods Unwilling
Item
9. man of childbearing age who do not want follow the instructions about sexual activities and condom use during the days following the treatment of brachytherapy and / or unwilling to hold (him or her partner) effective contraception for the duration of the study
boolean
C0079399 (UMLS CUI [1,1])
C0015895 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Malignant disease | Exception Superficial basal cell carcinoma | Exception Basal cell carcinoma
Item
10. any concomitant or previous malignant disease in the past five years with the exception of superficial basal cell carcinoma or non-metastatic of the skin
boolean
C0442867 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0862889 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Systemic Chemotherapy | Status pre- Malignant disease
Item
11. any prior systemic chemotherapy within 5 years prior to inclusion for malignant disease in the medical history
boolean
C1883256 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0442867 (UMLS CUI [2,2])
Medical condition At risk Clinical Trial
Item
12. any coexisting medical condition that in the opinion of the investigator could be a risk in this study
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Patient rights protection
Item
13. patient protected by law
boolean
C0150300 (UMLS CUI [1])
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