Advanced Prostate Cancer Clinical Trial
— PROSTACOfficial title:
Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.
Verified date | January 2020 |
Source | Centro Nacional de Investigaciones Oncologicas CARLOS III |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
PROSTAC is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with docetaxel or cabazitaxel
Status | Active, not recruiting |
Enrollment | 402 |
Est. completion date | December 2020 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 99 Years |
Eligibility |
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 docetaxel 75mg/m2 every 3 weeks or cabazitaxel 20-25mg/m2 every 3 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Fundacion Centro Oncologico de Galicia | A Coruna | |
Spain | Hospital Universitario Vall D'Hebron | Barcelona | |
Spain | Hospital de Ciudad Real | Ciudad Real | |
Spain | Hospital Universitario Reina Sofia | Cordoba | |
Spain | Hospital Universitario Virgen de las Nieves | Granada | |
Spain | Hospital Universitario de Guadalajara | Guadalajara | |
Spain | Hospital de Especialidades de Jerez de la Frontera | Jerez de la Frontera | Cádiz |
Spain | ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona |
Spain | Hospital Universitario de Canarias | La Laguna | Tenerife |
Spain | Centro Integral Oncológico Clara Campal | Madrid | |
Spain | Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario Clinico San Carlos | Madrid | |
Spain | Hospital Universitario Gregorio Maranon | Madrid | |
Spain | Anatomical Pathology PROCURE | Malaga | |
Spain | Hospital Regional Universitario Virgen de la Victoria | Malaga | |
Spain | Hospital Universitario Virgen de la Victoria | Málaga | |
Spain | Hospital Althaia Manresa | Manresa | Barcelona |
Spain | Hospital Costa del Sol | Marbella | Málaga |
Spain | Hospital Morales Messeguer | Murcia | |
Spain | Hospital Son Espases | Palma de Mallorca | |
Spain | Complejo Hospitalario de Navarra | Pamplona | Navarra |
Spain | Complejo Hospitalario de Pontevedra | Pontevedra | |
Spain | Hospital Universitario de Santiago | Santiago de Compostela | A Coruña |
Spain | Hospital Universitario La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Centro Nacional de Investigaciones Oncologicas CARLOS III |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 48 months | ||
Secondary | To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival | 48 months | ||
Secondary | To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al | 48 months | ||
Secondary | To compare the prognostic value of the gene-expression signature described by Olmos et al versus the gene-expression signature described by Ross et al (Lancet Oncol, 2012) | 48 months | ||
Secondary | To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients | 48 months | ||
Secondary | To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts | 48 months | ||
Secondary | To analyze the prognostic value of AR splicing variants, serum chromogranine and serum testosterone levels measured by ultrasensitive method in these both cohorts of patients | 48 months | ||
Secondary | To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients | 48 months |
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