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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Radium-223 Dichloride (Alpharadin) DRKS00006460 NCT01618370 in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases (Subsequent Cycle) - Radium 223 Dichloride (Alpharadin) - Subsequent Cycle

- 2/16/22 - 1 form, 8 itemgroups, 57 items, 1 language
Itemgroups: Subject Visit, Assessment of Disease Progression, Vital Signs, BPI-SF, ECOG Performance Status, Hematology (with DBC), General Chemistry - Serum, Skeletal Related Events
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product. NCT01618370

Eligibility DRKS00005404 NCT00617669 Prostate Cancer - Eligibility NCT00617669

- 9/28/21 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
see http://clinicaltrials.gov/ct2/show/record/NCT00617669 Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

Eligibility DRKS00006523 NCT01234311 Prostate Cancer - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 35 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01234311

Eligibility DRKS00003665 NCT01204710 Prostate Cancer - Eligibility

- 9/27/21 - 1 form, 2 itemgroups, 28 items, 2 languages
Itemgroups: Inclusion Criteria, Exclusion Criteria
ODM derived from http://clinicaltrials.gov/show/NCT01204710

Eligibility Prostatic Neoplasms NCT00537381

- 9/27/21 - 1 form, 1 itemgroup, 10 items, 1 language
Itemgroup: Inclusion Criteria
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00537381

Eligibility Prostate Cancer NCT01009736

- 9/27/21 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: Inclusion Criteria
Effects of Tomato-Soy Juice on Biomarkers in Patients With Prostate Cancer Undergoing Prostatectomy; ODM derived from: https://clinicaltrials.gov/show/NCT01009736

Eligibility Prostate Cancer NCT00881725

- 9/27/21 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
A Study of Pre-operative Metformin in Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00881725

Eligibility Prostate Cancer NCT00716794

- 9/27/21 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: Criteria
A Phase I/II Study of HE3235 in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00716794

Eligibility DRKS00009656 NCT00069745 Prostate Cancer - Eligibility

- 9/20/21 - 1 form, 3 itemgroups, 34 items, 2 languages
Itemgroups: Inclusion criteria, Exclusion criteria, Medical Concepts
Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen Inclusion Criteria: - Stage D2 metastatic prostate cancer - Progression after one prior chemotherapy - ECOG Performance status equal / less than 2 - Life expectancy > 3 months - Surgical or medical castration - Adequate bone marrow, hepatic and renal functions - Informed consent Exclusion Criteria: - More than one prior chemotherapy - Prior platinum containing compounds - Prior malignancy - Prior significant RT/radionuclide therapy - Major GI surgery or GI disease affecting absorption - Disease with contraindication to steroids - Brain metastases

Prostatic Surgical Intervention GSK study Prostatic neoplasms NCT00883909

- 9/20/21 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: Administrative data, prostate surgery, Prostate surgery
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate

Local Pathology Results GSK study Prostatic neoplasms NCT00883909

- 9/20/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Administrative data, Pathology Results
Study ID: 103094 Clinical Study ID: ARI103094 Study Title: ARI103094-Follow-Up Study for REDUCE Study Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00883909 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Neoplasms, Prostate CRF Seiten: 934-977

Eligibility Neoplasms, Prostate DRKS00009657 NCT00056407 - Eligibility Neoplasms, Prostate NCT00056407

- 9/20/21 - 1 form, 2 itemgroups, 12 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00056407

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