Patients With High-risk Prostate Cancer
Conditions
Brief summary
The detection and quantification of Circulating tumor cells CTCs in peripheral blood of patients with prostate adenocarcinoma may be useful at least for: Getting a correct stratification of patients with high-risk prostate cancer (PCa). Set the prognosis at baseline. Evaluate the response to different treatments (predictive value and monitoring). Establish individualized therapies.
Detailed description
Prospective analysis of biologic samples from peripheral blood of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with AD. Following the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system (Veridex), in 4 periods of time: 1. prior to any treatment; 2. following AD and prior to RT; and 3. following the end of RT (1-3 months afterwards). 4. six to twelve months following the end of RT in those patients with 0 CTCs in the first determination and positive CTCs in the second or third determination Comparison between the expression of CTCs in peripheral blood before and following AD and RT will be performed. The quantification of the CTCs obtained in these phases of treatment will be correlated with the treatment results in terms of biochemical failure according to Phoenix definition, distant metastasis rate and overall survival to identify a significant prognostic relationship and to determine the potential effect of the treatment in the number of CTCs Our working group will include 65 patients because the amount is based on routine clinical activity can be safely enrolled in the project development time by the participating centers.
Interventions
None listed
Sponsors
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged \> 18 with capacity to give informed consent. * Patients with histologically confirmed prostate cancer. * Patients with a high risk factor: PSA\> 20 ng / ml, Gleason 8-10 and / or stage T3a-b, N0M0 (NCCN 2011, stage IIB-III AJCC classification 2010). Staging by: Histology-Gleason score-, PSA, TR, ECO TR, CT, MRI. * Patients who accept radical treatment with radiotherapy. * Patients who give written informed consent to participate in the study
Exclusion criteria
* Any patient diagnosed with prostate cancer, which does not meet the prerequisites. * Any patients with another malignancy diagnosed in the past 5 years (except basal cell or squamous cell carcinoma of skin). * Any patient who has prostate biopsy performed 7 days prior to study entry. * Patients who have received prior treatment with hormonal therapy, chemotherapy or radiotherapy. * Patients with PSA\> 100 ng / ml. * Any situation or condition of the patient which in the opinion of the investigator, advised against participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Basal | Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Failure-free Survival; | 4 years | Phoenix criteria (PSA Nadir +2 ng/mL) |
| Overall Survival | 4 years | Defined as death due to any cause |
| Metastasis-free Survival | 4 years | Defined as freedom from distant metastasis |
| Cause Specific Survival | 4 years | Defined as death caused by prostate cancer |
Countries
Spain
Participant flow
Recruitment details
66 patients included: 2 patients were not included in the final enrollment due to inegibility criteria
Participants by arm
| Arm | Count |
|---|---|
| CTCs Analysis Prospective analysis of biologic samples from PB of 65 patients with localized high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with ADT. Following the sign of the informed consent of the patient, the blood samples will be analyzed for CTCs using an immunomagnetic method based on the CellSearch system in 4 periods of time:
1. Prior to any treatment (baseline- Time 1)
2. Following ADT and prior to RT (Time 2)
3. Following the end of RT (1-3 months afterwards) (Time 3)
4. Following 9 -12 after RT in those cases in cases of one turn (+) in CTCs in the 2nd or 3rd determination | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | CTCs Analysis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 50 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 71 years |
| Clinical N Stage according to AJCC seventh edition N0 Best prognosis | 53 Participants |
| Clinical N Stage according to AJCC seventh edition N1 Worst prognosis | 13 Participants |
| Clinical T Stage according to AJCC seventh edition T1 Best prognosis | 1 Participants |
| Clinical T Stage according to AJCC seventh edition T2 | 17 Participants |
| Clinical T Stage according to AJCC seventh edition T3 Worst prognosis | 48 Participants |
| Gleason score Gleason sum =< 6 Better prognosis | 5 Participants |
| Gleason score Gleason sum = 7 | 33 Participants |
| Gleason score Gleason sum = 8 - 10 Worst prognosis | 28 Participants |
| Median PSA (ng/mL) | 12.6 ng/mL |
| PSA pre-treatment 10 - 20 ng/mL | 19 Participants |
| PSA pre-treatment < 10 ng/mL | 24 Participants |
| PSA pre-treatment > 20 ng/mL | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Radiotherapy dose (Gy) 3D Conformal RT | 76.3 Gy |
| Radiotherapy dose (Gy) IMRT-IGRT | 81.7 Gy |
| Region of Enrollment Spain | 66 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 65 |
| other Total, other adverse events | 15 / 65 |
| serious Total, serious adverse events | 7 / 65 |
Outcome results
Primary
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.
Time frame: Basal
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with 0 CTCs | 60 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with =>1 CTCs | 5 Participants |
Primary
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
(Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Time frame: Post-neoadjuvant hormone therapy and prior to radiotherapy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with 0 CTCs | 54 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with =>1 CTCs | 8 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | No Data | 3 Participants |
Primary
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
(Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Time frame: Post-radiotherapy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with 0 CTCs | 48 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with =>1 CTCs | 11 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | No Data | 6 Participants |
Primary
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
(Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Time frame: 9 - 12 months post-radiotherapy in cases with positivation after basal visit
Population: Patients with positivation after basal visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with 0 CTCs | 12 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Number of Participants With Circulating Tumor Cells in the Peripheral Blood | Number of Participants with =>1 CTCs | 1 Participants |
Secondary
Biochemical Failure-free Survival;
Phoenix criteria (PSA Nadir +2 ng/mL)
Time frame: 4 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Biochemical Failure-free Survival; | Yes | 64 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Biochemical Failure-free Survival; | No | 1 Participants |
Secondary
Cause Specific Survival
Defined as death caused by prostate cancer
Time frame: 4 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Cause Specific Survival | Yes | 65 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Cause Specific Survival | No | 0 Participants |
Secondary
Metastasis-free Survival
Defined as freedom from distant metastasis
Time frame: 4 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Metastasis-free Survival | Yes | 64 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Metastasis-free Survival | No | 1 Participants |
Secondary
Overall Survival
Defined as death due to any cause
Time frame: 4 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Overall Survival | Yes | 59 Participants |
| Circulating Prostatic Tumor Cells in the Peripheral Blood | Overall Survival | No | 6 Participants |