Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02925702 |
Date of registration:
|
29/09/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.
PRORADIUM |
Scientific title:
|
Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resitant Prostate Cancer Patients Treated With Radium-223. |
Date of first enrolment:
|
February 2016 |
Target sample size:
|
161 |
Recruitment status: |
Active, not recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT02925702 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
|
|
Countries of recruitment
|
Spain
| | | | | | | |
Contacts
|
Name:
|
Rafael Morales, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hospital Vall d'Hebron |
|
Name:
|
David Olmos, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
CNIO-Centro Nacionald e Investigaciones Oncológicas |
|
Name:
|
Elena Castro, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
CNIO-Centro Nacionald e Investigaciones Oncológicas |
|
Name:
|
Maria Isabel Saez, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Hospital Universitario Virgen de la Victoria |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Male age = 18 years
2. Histologically confirmed adenocarcinome of the prostate
3. ECOG Performance Status = 2
4. Castration resistance must be documented with surgical or medical castration with
serum testosterone < 50 ng/mL (< 2.0 nM).
5. Men diagnosed with at least one metastatic lesion on CT or bone scan.
6. Documented biochemical and/or radiographic progression to previous treatment according
to PCWG2 criteria.
7. Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg
very 4 weeks intravenously
8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy
and/or radical prostatectomy.
9. Acceptable hematological, hepatic and renal functions.
Exclusion Criteria:
1. Previous cancer diagnosis, except those patients who had a localized malignant tumour
and who are five years cancer-free or those diagnosed with skin cancers (of
non-melanoma type) or excised in situ carcinomas.
2. Any condition or reason that, in the opinion of the Investigator, interferes with the
ability of the patient to participate in the trial, which places the patient at undue
risk, or complicates the interpretation of safety data
Age minimum:
18 Years
Age maximum:
99 Years
Gender:
Male
|
Health Condition(s) or Problem(s) studied
|
Advanced Prostate Cancer
|
Castration Resistant
|
Radium 223
|
Intervention(s)
|
Drug: Radium 223 55mBq/Kg every 4 weeks intravenously
|
Primary Outcome(s)
|
To validate the prognostic value for overall survival of serum bone metabolism markers descibed by Primo N Lara et al (JNCI 2014) in mCRPC patients treated with Radium-223
[Time Frame: Initially 48 months, currently 60 months]
|
Secondary Outcome(s)
|
To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients treated with Radium-223
[Time Frame: Initially 48 months, currently 60 months]
|
To analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223
[Time Frame: Initially 48 months, currently 60 months]
|
To analyze the prognostic value for biochemical and/or radiological progression-free survival of serum bone metabolism markers described by Primo N Lara et al in mCRPC patients treated with Radium-223
[Time Frame: Initially 48 months, currently 60 months]
|
To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients
[Time Frame: Initially 48 months, currently 60 months]
|
To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
[Time Frame: Initially 48 months, currently 60 months]
|
To validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients
[Time Frame: Initially 48 months, currently 60 months]
|
Exploratory aims include: Validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients and analyze the prognostic value of the gene-expression signature described by Olmos et al on progression-free survival.
[Time Frame: Initially 48 months, currently 60 months]
|
Secondary ID(s)
|
CNI-RAD-2016-01
|
IBIMA-CNIO-CP-03-2015
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|