Clinical trial NCT02155998: Non-Interventional Study PREVENT
Official title: A Non-interventional Study of Postoperative or Post-Radiation trEatment Habits in Locally adVanced Prostate Cancer patiENTs (High Risk)- PREVENT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative or Postradiation Adjuvant Androgen Deprivation Therapy in Locally Advanced Prostate Cancer (High and Very High Risk) Patients
Keywords: prostate adenocarcinoma, locally advanced prostate cancer with high and very high risk of recurrence, adjuvant endocrine treatment, prostate specific antigen
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients with locally advanced prostate cancer with high and very high risk of recurrence, who underwent surgery or radiotherapy within 3 months prior to enrolment, 18 years and older, consented to participate in this non-interventional study, being treated for prostate cancer in the oncology institutions / departments in the Russian Federation.

Brief summary: This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.

Detailed description: This is a multicentre, non-interventional, prospective study to be carried out in representative medical institutions in order to get the information on administration of postoperative and post-radiation adjuvant androgen deprivation therapy (including "go" / "no go" decision, regimens, dosages and duration) used in locally advanced prostate cancer patients with high and very high risk of recurrence in Russia.

No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

It is planned to enrol 200 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 6 - 10; there are no restrictions on minimum and maximum number of subjects per site in this study.

Eligibility criteria: Inclusion Criteria:

1. The voluntarily given informed consent, confirmed by the Informed Consent Form, properly signed by both the subject and the investigator.
2. Locally advanced stage of PCa (stage T3-T4, Nx-N0, M0: prostate adenocarcinoma with extracapsular invasion (T3a) or invasion to the seminal vesicles (T3b), invasion to adjacent structures (T4) but without lymphatic invasion (N0) nor metastasis (M0))
3. Prostatectomy or radiotherapy completed within 3 months prior to the study enrolment
4. High (T3a or Gleason score = 8-10 or PCA \>20 ng/ml) and very high (T3b-T4) risk of recurrence
5. Histologically confirmed diagnosis of prostate adenocarcinoma

Exclusion Criteria:

1. Patients participating in clinical trials
2. Any medical condition which on the opinion of the investigator may interfere with the patient's participation in the study, e.g. severe non-malignant concomitant disease which can affect life expectancy
3. Evidence of metastatic disease on imaging studies

Primary outcomes:
measure: Evaluation of adjuvant endocrine therapy: drugs used for androgen deprivation therapy, regimen, dose, duration
timeFrame: up to 15 months after LSI
Secondary outcomes:
measure: Data collection of patients characteristics (age, race, co-morbidities, family history of prostate cancer)
timeFrame: up to 15 months after LSI
measure: Data collection of disease information ( disease stage - TNM, histology, Gleason score, PSA level, prior prostate cancer surgery/radiotherapy -types, imaging techniques, neoadjuvant and adjuvant therapy(medications by groups, orchidectomy)
timeFrame: up to 15 months after LSI
measure: Proportion of patients with double increase in PSA level during 1 year follow-up
timeFrame: up to 15 months after LSI
measure: Proportion of progression-free patients after 1 year follow-up
timeFrame: up to 15 months after LSI
measure: Proportion of patients with disease progression after 1 year follow-up
timeFrame: up to 15 months after LSI
measure: Proportion of patients having biochemical relapse after 1 year follow-up
timeFrame: up to 15 months after LSI
measure: Proportion of patients having clinical relapse (local or metastatic) after 1 year follow-up
timeFrame: up to 15 months after LSI
measure: Evaluation of deaths among BRCAm+ patient
timeFrame: up to 15 months after LSI
Other outcomes:
Locations:
city: Balashikha
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Tumen
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Karin Otter
role: STUDY_DIRECTOR
affiliation: Moscow Research Institute of Oncology named after PA Herzen
name: Boris Alexeev
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Cancer Research Center named after NN Blokhin
name: Vsevolod Matveev
role: PRINCIPAL_INVESTIGATOR
References: