Eligibility Localized Prostate Cancer NCT01902680

1 Formulários

StudyEvent: Eligibility
1. Eligibility Localized Prostate Cancer NCT01902680

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Localized Prostate Cancer NCT01902680