Trial Outcomes & Findings for Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy (NCT NCT01800058)
NCT ID: NCT01800058
Last Updated: 2020-06-26
Results Overview
Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.
Recruitment status
COMPLETED
Target enrollment
68 participants
Primary outcome timeframe
Basal
Results posted on
2020-06-26
Participant Flow
66 patients included: 2 patients were not included in the final enrollment due to inegibility criteria
Participant milestones
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
1. prior to any treatment;
2. following AD and prior to RT; and
3. following the end of RT (1-3 months afterwards).
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
1. prior to any treatment;
2. following AD and prior to RT; and
3. following the end of RT (1-3 months afterwards).
The quantification of CTC in blood samples will be done with the CellSearch® system.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
Baseline characteristics by cohort
| Measure |
CTCs Analysis
n=66 Participants
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
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
66 Participants
n=5 Participants
|
|
Median PSA (ng/mL)
|
12.6 ng/mL
n=5 Participants
|
|
PSA pre-treatment
< 10 ng/mL
|
24 Participants
n=5 Participants
|
|
PSA pre-treatment
10 - 20 ng/mL
|
19 Participants
n=5 Participants
|
|
PSA pre-treatment
> 20 ng/mL
|
23 Participants
n=5 Participants
|
|
Gleason score
Gleason sum =< 6 Better prognosis
|
5 Participants
n=5 Participants
|
|
Gleason score
Gleason sum = 7
|
33 Participants
n=5 Participants
|
|
Gleason score
Gleason sum = 8 - 10 Worst prognosis
|
28 Participants
n=5 Participants
|
|
Clinical T Stage according to AJCC seventh edition
T1 Best prognosis
|
1 Participants
n=5 Participants
|
|
Clinical T Stage according to AJCC seventh edition
T2
|
17 Participants
n=5 Participants
|
|
Clinical T Stage according to AJCC seventh edition
T3 Worst prognosis
|
48 Participants
n=5 Participants
|
|
Clinical N Stage according to AJCC seventh edition
N0 Best prognosis
|
53 Participants
n=5 Participants
|
|
Clinical N Stage according to AJCC seventh edition
N1 Worst prognosis
|
13 Participants
n=5 Participants
|
|
Radiotherapy dose (Gy)
3D Conformal RT
|
76.3 Gy
n=5 Participants
|
|
Radiotherapy dose (Gy)
IMRT-IGRT
|
81.7 Gy
n=5 Participants
|
PRIMARY outcome
Timeframe: BasalInitially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with 0 CTCs
|
60 Participants
|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with =>1 CTCs
|
5 Participants
|
PRIMARY outcome
Timeframe: Post-neoadjuvant hormone therapy and prior to radiotherapy(Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with 0 CTCs
|
54 Participants
|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with =>1 CTCs
|
8 Participants
|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
No Data
|
3 Participants
|
PRIMARY outcome
Timeframe: Post-radiotherapy(Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with 0 CTCs
|
48 Participants
|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with =>1 CTCs
|
11 Participants
|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
No Data
|
6 Participants
|
PRIMARY outcome
Timeframe: 9 - 12 months post-radiotherapy in cases with positivation after basal visitPopulation: Patients with positivation after basal visit
(Initially a cutoff point of \> 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline).
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=13 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with 0 CTCs
|
12 Participants
|
|
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Number of Participants with =>1 CTCs
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPhoenix criteria (PSA Nadir +2 ng/mL)
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Biochemical Failure-free Survival;
Yes
|
64 Participants
|
|
Biochemical Failure-free Survival;
No
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 yearsDefined as death due to any cause
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Overall Survival
Yes
|
59 Participants
|
|
Overall Survival
No
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 yearsDefined as freedom from distant metastasis
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Metastasis-free Survival
Yes
|
64 Participants
|
|
Metastasis-free Survival
No
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 yearsDefined as death caused by prostate cancer
Outcome measures
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 Participants
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
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
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Cause Specific Survival
Yes
|
65 Participants
|
|
Cause Specific Survival
No
|
0 Participants
|
Adverse Events
Circulating Prostatic Tumor Cells in the Peripheral Blood
Serious events: 7 serious events
Other events: 15 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 participants at risk
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
1. prior to any treatment;
2. following AD and prior to RT; and
3. following the end of RT (1-3 months afterwards).
The quantification of CTC in blood samples will be done with the CellSearch® system.
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|---|---|
|
Injury, poisoning and procedural complications
Postoperative of colon volvulus
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Infections and infestations
Sepsis
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenocarcinoma
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomia
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchoaspiration
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric GIST
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureter cancer
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Renal and urinary disorders
Urethral estenosis
|
1.5%
1/65 • Number of events 1 • 4 years
|
|
Renal and urinary disorders
Haematuria
|
1.5%
1/65 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
Circulating Prostatic Tumor Cells in the Peripheral Blood
n=65 participants at risk
Patients that satisfy inclusion criteria, and after signing informed consent, will extract 1 blood sample (7.5 mL):
1. prior to any treatment;
2. following AD and prior to RT; and
3. following the end of RT (1-3 months afterwards).
The quantification of CTC in blood samples will be done with the CellSearch® system.
|
|---|---|
|
Renal and urinary disorders
Late urinary symptoms Grade >= 2
|
13.8%
9/65 • Number of events 9 • 4 years
|
|
Gastrointestinal disorders
Late rectal symptoms Grade >= 2
|
9.2%
6/65 • Number of events 6 • 4 years
|
Additional Information
Almudena Zapatero, MD PhD
Hospital Universitario de La Princesa
Phone: +34 91 520 23 15
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60