Clinical trial NCT02362620: PROSTAC: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Docetaxel or Cabazitaxel.
Official title: Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resistant Prostate Cancer Patients Treated With Docetaxel or Cabazitaxel.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Prostate Cancer
Cabazitaxel
Docetaxel
Keywords: metastatic Castration Resistant Prostate Cancer
Taxanes
Biomarkers
Lead sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 402
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Castration-Resistant Prostate Cancer patients

Brief summary: 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

Detailed description: This study is a prospective biomarker study of patients with mCRPC undergoing treatment with docetaxel or cabazitaxel as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Eligibility 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 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

Primary outcomes:
measure: 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
timeFrame: 48 months
Secondary outcomes:
measure: To analyze the prognostic value of the gene-expression signature described by Olmos et al on biochemical and radiological progression-free survival
timeFrame: 48 months
measure: To analyze the prognostic value of early changes in the gene-expression signature described by Olmos et al
timeFrame: 48 months
measure: 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)
timeFrame: 48 months
measure: To validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients in these both cohorts of patients
timeFrame: 48 months
measure: To analyze the prognostic value of TMPRSS2-ERG rearrengement and PTEN loss in these cohorts
timeFrame: 48 months
measure: 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
timeFrame: 48 months
measure: To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
timeFrame: 48 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago
state: A Coruña
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO L'Hospitalet
state: Barcelona
city: Manresa
country: Spain
facility: Hospital Althaia Manresa
state: Barcelona
city: Jerez de la Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera
state: Cádiz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: A Coruna
country: Spain
facility: Fundacion Centro Oncologico de Galicia
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal
city: Malaga
country: Spain
facility: Anatomical Pathology PROCURE
city: Malaga
country: Spain
facility: Hospital Regional Universitario Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Head of Prostate Cancer Clinical Research Unit CNIO
name: David Olmos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: