Prostate Cancer
Conditions
Brief summary
A multicentre observational study on treatment patterns and ctDNA HRR evaluation in aggressive high-volume metastatic hormone-sensitive prostate cancer in Russian Federation
Detailed description
This is a multicentre observational study on treatment approaches, demographic and clinical characteristics and on HRRm evaluation in ctDNA in patients with high-aggressive high-volume mHSPC with known tumor HRRm status in Russian Federation. The study will sequentially include only those patients who have signed the informed consent form (ICF). No procedures will be applied to patients in addition to the routine clinical practice. Study population will consist of patients with high-aggressive (Gleason 8-10) high-volume mHSPC with available medical history and known tumor HRRm status, which has been determined from a tumour sample obtained from the patient as part of routine practice. It is estimated that approximately 400 patients will be enrolled in about 30 sites. In this case, the ratio of patients with HRR gene mutations (HRRm) to patients with wild-type HRR genes (HRRwt) will be approximately 5:3 (250 HRRm and 150 HRRwt), so that both populations are represented in the study sample, including patients without mutations. The study will include two visits carried out according to routine clinical practice. At baseline visit (visit 1) demographic and clinical characteristics and treatment approaches from the date of high-aggressive high-volume mPC diagnosis (date of first metastases verification) till enrollment will be collected based on the patient's medical records. In case of absence of data required to be collected by the protocol, additional data may be obtained during patient's interview directly and recorded in the source documents related to the visit. For ctDNA and ctDNA-based HRRm testing (by NGS) routinely collected blood samples will be used. Testing will be performed in central laboratories. Visit 2 (final visit) will be conducted at the time of disease progression or after 12 (±3) months (whichever occurs first) to collect follow-up data on progression to mCRPC and subsequent treatment, if applicable. If the patient is unable to visit the study site (e.g. in case the patient is being treated and observed at the place of residence) the data collection of visits 2 could be carried out via telephone contact. All study data will be entered into electronic case report form (eCRF). The study physician will be responsible for ensuring that all required data is collected and entered into the eCRF. Overall expected duration of the study (from the first patient inclusion to the final database lock) is about 38 months, or until 400 eligible patients are included to the study and data on these patients are collected (including follow-up data), whichever occurs first.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male patients aged ≥ 18 years old; 2. Signed ICF, including consent for blood samples ctDNA and ctDNA-based HRRm testing; 3. Metastatic hormone-sensitive prostate cancer (mHSPC) (de novo or progressed from earlier stages); 4. High-aggressive disease (Gleason 8-10); 5. High-volume disease (according to CHAARTED trial criteria: presence of 4 and more (≥4) bone metastases (including at least one (≥1) outside the vertebral column/pelvis) and/or 1 and more (≥1) visceral metastasis); 6. Availability of source medical documentation; 7. Known HRRm status based on tumour sample evaluation performed in routine practice.
Exclusion criteria
1. Participation in any interventional trial since the mPC diagnosis. 2. Progression to mCRPC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients received any ADT | 36 months | Proportion of patients received any Androgen deprivation therapy |
| Proportion of patients received ADT by each type and by each drug | 36 months | Proportion of patients received Androgen deprivation therapy by each type and by each drug |
| Proportion of patients received first generation antiandrogens | 36 months | Proportion of patients received first generation antiandrogens |
| Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC | 36 months | Proportion of patients received androgen receptor pathway inhibitors (ARPI) at mHSPC overall and by each drug; |
| Duration of ARPI therapy | 36 months | Duration (months) of androgen receptor pathway inhibitors (ARPI) therapy |
| Proportion of patients received any chemotherapy at mHSPC | 36 months | Proportion of patients received any chemotherapy at metastatic hormone-sensitive prostate cancer |
| Duration of chemotherapy | 36 months | Duration (months) of chemotherapy, No. of cycles of chemotherapy; |
| Proportion of patients received radiation therapy | 36 months | Proportion of patients received radiation therapy (RT) overall and by each type (if applicable); |
| Proportion of patients with each radiation area | 36 months | Proportion of patients with each radiation area (if applicable) (to be calculated in patients who received any RT); |
| Proportion of patients underwent surgery at mHSPC | 36 months | Proportion of patients underwent surgery at Metastatic hormone-sensitive prostate cancer stage overall and by each type (if applicable); |
| Proportion of patients received triplet therapy at mHSPC | 36 months | Proportion of patients received triplet therapy (ADT + ARPI + chemotherapy) at Metastatic hormone-sensitive prostate cancer overall and by each ARPI; |
| Time from mPC diagnosis to progression to mCRPC | 36 months | Time from Metastatic prostate cancer diagnosis to progression to Metastatic castration-resistant prostate cancer (mCRPC) (calculated between the date of confirmed metastatic disease diagnosis and the date of progression to mCRPC) in the total sample and in different subgroups (HRRm/HRRwt, ctDNA+/ctDNA-, different therapeutical approaches); |
| Proportion of patients with each site of disease progression | 36 months | Proportion of patients with each site of disease progression (metastases); |
| Testosterone level at the time of mCRPC | 36 months | Testosterone level (nmol/l) at the time of castrate-resistant disease (mCRPC diagnosis); |
| Proportion of patients with presence of pathogenic mutations in HRR genes in ctDNA | 36 months | Proportion of patients with presence of pathogenic mutations in Homologous recombination repair (HRR) genes detected in culating tumor DNA (ctDNA) by Next Generation Sequencing (NGS) overall and by each gene. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age at the diagnosis of high-aggressive high-volume mPC | 36 months | Age at the diagnosis of high-aggressive high-volume Metastatic prostate cancer (mPC) |
| Proportion of patients of different races and ethnicities | 36 months | Proportion of patients of different races and ethnicities overall and in subgroups HRRm/HRRwt; |
| Proportion of patients with presence of a family oncology history | 36 months | Proportion of patients with presence of a family oncology history (first degree relatives) overall and by each disease, in the total sample and in subgroups HRRm/HRRwt; |
| Proportion of patients with a personal oncology history | 36 months | Proportion of patients with a personal oncology history overall and by each disease, in the total sample and in subgroups HRRm/HRRwt; |
| Proportion of patients with each category by ECOG assessmen | 36 months | Proportion of patients with each category by Eastern Cooperative Oncology Group (ECOG) assessment at the inclusion; |
| Proportion of patients with each type of mPC diagnosi | 36 months | Proportion of patients with each type of Metastatic prostate cancer (mPC) diagnosis (de novo, metachronous); |
| Proportion of patients with each stage by TNM classification | 36 months | Proportion of patients with each stage by TNM classification; |
| Proportion of patients with each histological type of tumor | 36 months | Proportion of patients with each histological type of tumor (types of adenocarcinoma); |
| Proportion of patients with each category by Gleason scale | 36 months | Proportion of patients with each category (8 (4+4), 8 (3+5), 8 (5+3), 9, 10)) by Gleason scale, in the total sample and in subgroups (de novo and in metachronous mPC, HRRm/HRRwt, ctDNA+/ctDNA-); |
| Time from initial diagnosis to mPC diagnosis | 36 months | Time from initial diagnosis to mPC diagnosis (calculated for patients with metachronous disease, as a time period between the date of initial diagnosis of PC and the date of confirmed metastatic disease diagnosis); |
| Proportion of patients with each localization of metastases at the diagnosis of mPC | 36 months | Proportion of patients with each localization of metastases at the diagnosis of mPC (confirmed metastatic disease), symptomatic or not; |
| PSA level at the diagnosis of mPC | 36 months | PSA level at the diagnosis of mPC (confirmed metastatic disease); |
| Proportion of patients with each HRR mutation among all HRRm patient | 36 months | Proportion of patients with each HRR mutation among all HRRm patients, in the total sample and in subgroups (de novo and in metachronous mPC, ctDNA+/ctDNA-); |
| Proportion of patients with each source of tumor sample | 36 months | Proportion of patients with each source of tumor sample (primary tumor, metastases), which was used for the HRRm status determination in routine practice; |
| Proportion of patients with presence of ctDNA | 36 months | Proportion of patients with presence of ctDNA, in the total sample and in subgroups (de novo and in metachronous mPC, HRRm/HRRwt); |
| ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate | 36 months | ctDNA HRRm/HRRwt and tumor HRRm/HRRwt coincidence rate. |
Countries
Russia
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed