ID

43864

Description

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

Link

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

Keywords

Versions (2)
  1. 6/26/17 6/26/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer DRKS00004405 NCT01717677 DRKS00004405

English

Eligibility Prostate Cancer NCT01717677 DRKS00004405

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Prostate Adenocarcinoma

Data type

boolean

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

Gender and Age

Data type

boolean

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

Time of Recruitment

Data type

boolean

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

TNM Prostate tumor staging

Data type

text

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

PSA

Data type

boolean

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

Gleason Score

Data type

boolean

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

ECOG Performance Status

Data type

boolean

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

Prostate Biopsy

Data type

boolean

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

IPSS score

Data type

boolean

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

Urine flow

Data type

boolean

Alias
UMLS CUI [1]
C0232851
Exclusion Criteria
Description

Exclusion Criteria

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

Unifocal Gleason 6 cancer

Data type

boolean

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

Treatment for BPH

Data type

boolean

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

Pelvic radiotherapy

Data type

boolean

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

Life expectancy

Data type

boolean

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

ASA

Data type

boolean

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

Urinary Retention

Data type

boolean

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

Prostate volume

Data type

boolean

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

Median prostate lobe

Data type

boolean

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

Inflammatory bowel disease

Data type

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)
Description

Malignant Neoplasms

Data type

boolean

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

Contraindication

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Prostate Cancer NCT01717677 DRKS00004405

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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