ID

43864

Beskrivning

Responsible Party: Association of Urogenital Oncology (AUO) ClinicalTrials.gov Identifier: NCT01717677 History of Changes Other Study ID Numbers: AP 65/11 DRKS00004405 ( Registry Identifier: Freiburger Register ) Study First Received: October 26, 2012 Last Updated: February 7, 2017 Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk (PREFERE) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01717677

Länk

https://clinicaltrials.gov/ct2/show/NCT01717677

Nyckelord

Versioner (2)
  1. 2017-06-26 2017-06-26 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00004405 NCT01717677 DRKS00004405

Engelsk

Eligibility Prostate Cancer NCT01717677 DRKS00004405

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol)
Beskrivning

Prostate Adenocarcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
Men aged 18-75 years
Beskrivning

Gender and Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Recruitment within 3 months after histological confirmation
Beskrivning

Time of Recruitment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2949735
UMLS CUI [1,2]
C0040223
Localized prostata cancer <= cT2a, NX or N0 M0
Beskrivning

TNM Prostate tumor staging

Datatyp

text

Alias
UMLS CUI [1]
C0474935
PSA <= 10 ng / ml
Beskrivning

PSA

Datatyp

boolean

Alias
UMLS CUI [1]
C0138741
Gleason score <= 7a (3 +4)
Beskrivning

Gleason Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0332326
ECOG performance status 0 or 1
Beskrivning

ECOG Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
<= 30% positive biopsy cores with largest contiguous tumor length <= 5 mm
Beskrivning

Prostate Biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0194804
IPSS score < 18
Beskrivning

IPSS score

Datatyp

boolean

Alias
UMLS CUI [1]
C2827405
Urine flow (Qmax):> 15 ml / s
Beskrivning

Urine flow

Datatyp

boolean

Alias
UMLS CUI [1]
C0232851
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Unifocal Gleason 6 cancer <1mm
Beskrivning

Unifocal Gleason 6 cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0332331
History of treatment for BPH e.g. TURP, HIFU or cryotherapy
Beskrivning

Treatment for BPH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1704272
History of radiation therapy to the pelvis
Beskrivning

Pelvic radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0436276
Life expectancy <10 years
Beskrivning

Life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
ASA >= 4
Beskrivning

ASA

Datatyp

boolean

Alias
UMLS CUI [1]
C1531480
Post-void residual urine > 50 ml
Beskrivning

Urinary Retention

Datatyp

boolean

Alias
UMLS CUI [1]
C0080274
Prostate volume on transrectal ultrasound > 60 cm3
Beskrivning

Prostate volume

Datatyp

boolean

Alias
UMLS CUI [1]
C1441416
Large median prostate lobe visualized on transrectal ultrasound
Beskrivning

Median prostate lobe

Datatyp

boolean

Alias
UMLS CUI [1]
C0227972
Chronic intestinal inflammatory disease covering the rectum
Beskrivning

Inflammatory bowel disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0021390
Other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma)
Beskrivning

Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
Contraindications for prostatectomy, radiation therapy or Active Surveillance
Beskrivning

Contraindication

Datatyp

boolean

Alias
UMLS CUI [1]
C0522473
Patients refusing written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Prostate Cancer NCT01717677 DRKS00004405

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Prostate Adenocarcinoma
Item
Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol)
boolean
C0007112 (UMLS CUI [1])
Gender and Age
Item
Men aged 18-75 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Time of Recruitment
Item
Recruitment within 3 months after histological confirmation
boolean
C2949735 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
TNM Prostate tumor staging
Item
Localized prostata cancer <= cT2a, NX or N0 M0
text
C0474935 (UMLS CUI [1])
PSA
Item
PSA <= 10 ng / ml
boolean
C0138741 (UMLS CUI [1])
Gleason Score
Item
Gleason score <= 7a (3 +4)
boolean
C0332326 (UMLS CUI [1])
ECOG Performance Status
Item
ECOG performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Prostate Biopsy
Item
<= 30% positive biopsy cores with largest contiguous tumor length <= 5 mm
boolean
C0194804 (UMLS CUI [1])
IPSS score
Item
IPSS score < 18
boolean
C2827405 (UMLS CUI [1])
Urine flow
Item
Urine flow (Qmax):> 15 ml / s
boolean
C0232851 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Unifocal Gleason 6 cancer
Item
Unifocal Gleason 6 cancer <1mm
boolean
C0332331 (UMLS CUI [1])
Treatment for BPH
Item
History of treatment for BPH e.g. TURP, HIFU or cryotherapy
boolean
C0087111 (UMLS CUI [1,1])
C1704272 (UMLS CUI [1,2])
Pelvic radiotherapy
Item
History of radiation therapy to the pelvis
boolean
C0436276 (UMLS CUI [1])
Life expectancy
Item
Life expectancy <10 years
boolean
C0023671 (UMLS CUI [1])
ASA
Item
ASA >= 4
boolean
C1531480 (UMLS CUI [1])
Urinary Retention
Item
Post-void residual urine > 50 ml
boolean
C0080274 (UMLS CUI [1])
Prostate volume
Item
Prostate volume on transrectal ultrasound > 60 cm3
boolean
C1441416 (UMLS CUI [1])
Median prostate lobe
Item
Large median prostate lobe visualized on transrectal ultrasound
boolean
C0227972 (UMLS CUI [1])
Inflammatory bowel disease
Item
Chronic intestinal inflammatory disease covering the rectum
boolean
C0021390 (UMLS CUI [1])
Malignant Neoplasms
Item
Other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma)
boolean
C0006826 (UMLS CUI [1])
Contraindication
Item
Contraindications for prostatectomy, radiation therapy or Active Surveillance
boolean
C0522473 (UMLS CUI [1])
Informed Consent
Item
Patients refusing written informed consent
boolean
C0021430 (UMLS CUI [1])
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