Patients With High-risk Prostate CancerNCT01800058
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
An observational study of Patients With High-risk Prostate Cancer, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Patients With High-risk Prostate Cancer
- How many people
- 68 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2014to 21 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with prostate cancer at high risk (NCCN 2011), AJCC stage IIB-III, treated with 3D-CRT, IMRT dose escalation (with androgen deprivation (DA))
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706
About this study
Official title: Prognostic Value of the Levels of Circulating Tumor Cells (CTCs) in Peripheral Blood in Patients With Prostate Cancer at High Risk (Clinical Stages IIB-III) Treated Radically With Radiotherapy and Hormone Therapy.
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.
Read the 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:
- prior to any treatment;
- following AD and prior to RT; and
- following the end of RT (1-3 months afterwards).
- 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.
- Conditions
- Patients With High-risk Prostate Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basal
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).
Measured: Post-neoadjuvant hormone therapy and prior to radiotherapy
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).
Measured: Post-radiotherapy
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).
Measured: 9 - 12 months post-radiotherapy in cases with positivation after basal visit
Secondary outcomes (4)
Biochemical Failure-free Survival;
Phoenix criteria (PSA Nadir +2 ng/mL)
Measured: 4 years
Overall Survival
Defined as death due to any cause
Measured: 4 years
Metastasis-free Survival
Defined as freedom from distant metastasis
Measured: 4 years
Cause Specific Survival
Defined as death caused by prostate cancer
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJan 2014
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Patients With High-risk Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Almudena Zapatero, MD, PhD, PI, Principal investigator, Radiation Oncology Department_Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800058
- Sponsor's protocol ID
- CaPr-RTCTC-01/PI 197
- Status last verified
- Jun 2020
- First submitted
- 18 Feb 2013
- Last updated
- 26 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Damber JE, Aus G. Prostate cancer. Lancet. 2008 May 17;371(9625):1710-21. doi: 10.1016/S0140-6736(08)60729-1.
PubMed 18486743Zelefsky MJ, Yamada Y, Fuks Z, Zhang Z, Hunt M, Cahlon O, Park J, Shippy A. Long-term results of conformal radiotherapy for prostate cancer: impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1028-33. doi: 10.1016/j.ijrobp.2007.11.066. Epub 2008 Feb 14.
PubMed 18280056Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.
PubMed 17765406Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. doi: 10.1200/JCO.2007.13.9881. Epub 2008 Jan 2.
PubMed 18172188Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. doi: 10.1200/JCO.2007.14.9021. Epub 2008 Apr 14.
PubMed 18413638Shaffer DR, Leversha MA, Danila DC, Lin O, Gonzalez-Espinoza R, Gu B, Anand A, Smith K, Maslak P, Doyle GV, Terstappen LW, Lilja H, Heller G, Fleisher M, Scher HI. Circulating tumor cell analysis in patients with progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Apr 1;13(7):2023-9. doi: 10.1158/1078-0432.CCR-06-2701.
PubMed 17404082Zapatero A, Rios P, Marin A, Minguez R, Garcia-Vicente F. Dose escalation with three-dimensional conformal radiotherapy for prostate cancer. Is more dose really better in high-risk patients treated with androgen deprivation? Clin Oncol (R Coll Radiol). 2006 Oct;18(8):600-7. doi: 10.1016/j.clon.2006.06.010.
PubMed 17051950Moreno JG, Miller MC, Gross S, Allard WJ, Gomella LG, Terstappen LW. Circulating tumor cells predict survival in patients with metastatic prostate cancer. Urology. 2005 Apr;65(4):713-8. doi: 10.1016/j.urology.2004.11.006.
PubMed 15833514Fehm T, Sagalowsky A, Clifford E, Beitsch P, Saboorian H, Euhus D, Meng S, Morrison L, Tucker T, Lane N, Ghadimi BM, Heselmeyer-Haddad K, Ried T, Rao C, Uhr J. Cytogenetic evidence that circulating epithelial cells in patients with carcinoma are malignant. Clin Cancer Res. 2002 Jul;8(7):2073-84.
PubMed 12114406Zapatero A, Minguez R, Nieto S, Martin de Vidales C, Garcia-Vicente F. Post-treatment prostate biopsies in the era of three-dimensional conformal radiotherapy: what can they teach us? Eur Urol. 2009 Apr;55(4):902-9. doi: 10.1016/j.eururo.2008.04.076. Epub 2008 May 7.
PubMed 18485578Zapatero A, Garcia-Vicente F, Martin de Vidales C, Cruz Conde A, Ibanez Y, Fernandez I, Rabadan M. Long-term results after high-dose radiotherapy and adjuvant hormones in prostate cancer: how curable is high-risk disease? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1279-85. doi: 10.1016/j.ijrobp.2010.07.1975. Epub 2010 Oct 6.
PubMed 20932659Olivier Gomez C, Carballido Rodriguez J. [Circulating tumor cells: isolation, quantification, and relevance of their translation into clinical practice]. Actas Urol Esp. 2010 Jan;34(1):3-5. No abstract available. Spanish.
PubMed 20223125Alix-Panabieres C, Riethdorf S, Pantel K. Circulating tumor cells and bone marrow micrometastasis. Clin Cancer Res. 2008 Aug 15;14(16):5013-21. doi: 10.1158/1078-0432.CCR-07-5125.
PubMed 18698019Mocellin S, Keilholz U, Rossi CR, Nitti D. Circulating tumor cells: the 'leukemic phase' of solid cancers. Trends Mol Med. 2006 Mar;12(3):130-9. doi: 10.1016/j.molmed.2006.01.006. Epub 2006 Feb 20.
PubMed 16488189Cabanes A, Vidal E, Aragones N, Perez-Gomez B, Pollan M, Lope V, Lopez-Abente G. Cancer mortality trends in Spain: 1980-2007. Ann Oncol. 2010 May;21 Suppl 3:iii14-20. doi: 10.1093/annonc/mdq089.
PubMed 20427355
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the Levels of Circulating Tumor Cells (CTCs) in Peripheral Blood in Patients With Prostate Cancer at High Risk (Clinical Stages IIB-III) Treated Radically With Radiotherapy and Hormone Therapy.
- ClinicalTrials.gov ID
- NCT01800058
- Acronym / sponsor ID
- CaPr-RTCTC-01/PI 197
- Conditions
- Patients With High-risk Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Posted 26 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- prior to any treatment;
- following AD and prior to RT; and
- following the end of RT (1-3 months afterwards).
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with prostate cancer at high risk (NCCN 2011), AJCC stage IIB-III, treated with 3D-CRT, IMRT dose escalation (with androgen deprivation (DA))
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time frame: Basal
Initially a cutoff point of > 1 or more circulating cells per 7.5 mL of blood will be taken as the reference baseline.
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time frame: 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).
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time frame: 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).
Number of Participants With Circulating Tumor Cells in the Peripheral Blood
Time frame: 9 - 12 months post-radiotherapy in cases 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).
4 secondary outcomes
Biochemical Failure-free Survival;
Time frame: 4 years
Overall Survival
Time frame: 4 years
Metastasis-free Survival
Time frame: 4 years
Cause Specific Survival
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18486743Damber JE, Aus G. Prostate cancer. Lancet. 2008 May 17;371(9625):1710-21. doi: 10.1016/S0140-6736(08)60729-1.
- Background: PubMed 18280056Zelefsky MJ, Yamada Y, Fuks Z, Zhang Z, Hunt M, Cahlon O, Park J, Shippy A. Long-term results of conformal radiotherapy for prostate cancer: impact of dose escalation on biochemical tumor control and distant metastases-free survival outcomes. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1028-33. doi: 10.1016/j.ijrobp.2007.11.066. Epub 2008 Feb 14.
- Background: PubMed 17765406Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):67-74. doi: 10.1016/j.ijrobp.2007.06.054. Epub 2007 Aug 31.
- Background: PubMed 18172188Roach M 3rd, Bae K, Speight J, Wolkov HB, Rubin P, Lee RJ, Lawton C, Valicenti R, Grignon D, Pilepich MV. Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol. 2008 Feb 1;26(4):585-91. doi: 10.1200/JCO.2007.13.9881. Epub 2008 Jan 2.
- Background: PubMed 18413638Horwitz EM, Bae K, Hanks GE, Porter A, Grignon DJ, Brereton HD, Venkatesan V, Lawton CA, Rosenthal SA, Sandler HM, Shipley WU. Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer. J Clin Oncol. 2008 May 20;26(15):2497-504. doi: 10.1200/JCO.2007.14.9021. Epub 2008 Apr 14.
- Background: PubMed 17404082Shaffer DR, Leversha MA, Danila DC, Lin O, Gonzalez-Espinoza R, Gu B, Anand A, Smith K, Maslak P, Doyle GV, Terstappen LW, Lilja H, Heller G, Fleisher M, Scher HI. Circulating tumor cell analysis in patients with progressive castration-resistant prostate cancer. Clin Cancer Res. 2007 Apr 1;13(7):2023-9. doi: 10.1158/1078-0432.CCR-06-2701.
- Background: PubMed 17051950Zapatero A, Rios P, Marin A, Minguez R, Garcia-Vicente F. Dose escalation with three-dimensional conformal radiotherapy for prostate cancer. Is more dose really better in high-risk patients treated with androgen deprivation? Clin Oncol (R Coll Radiol). 2006 Oct;18(8):600-7. doi: 10.1016/j.clon.2006.06.010.
- Background: PubMed 15833514Moreno JG, Miller MC, Gross S, Allard WJ, Gomella LG, Terstappen LW. Circulating tumor cells predict survival in patients with metastatic prostate cancer. Urology. 2005 Apr;65(4):713-8. doi: 10.1016/j.urology.2004.11.006.
- Background: PubMed 12114406Fehm T, Sagalowsky A, Clifford E, Beitsch P, Saboorian H, Euhus D, Meng S, Morrison L, Tucker T, Lane N, Ghadimi BM, Heselmeyer-Haddad K, Ried T, Rao C, Uhr J. Cytogenetic evidence that circulating epithelial cells in patients with carcinoma are malignant. Clin Cancer Res. 2002 Jul;8(7):2073-84.
- Background: PubMed 18485578Zapatero A, Minguez R, Nieto S, Martin de Vidales C, Garcia-Vicente F. Post-treatment prostate biopsies in the era of three-dimensional conformal radiotherapy: what can they teach us? Eur Urol. 2009 Apr;55(4):902-9. doi: 10.1016/j.eururo.2008.04.076. Epub 2008 May 7.
- Background: PubMed 20932659Zapatero A, Garcia-Vicente F, Martin de Vidales C, Cruz Conde A, Ibanez Y, Fernandez I, Rabadan M. Long-term results after high-dose radiotherapy and adjuvant hormones in prostate cancer: how curable is high-risk disease? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1279-85. doi: 10.1016/j.ijrobp.2010.07.1975. Epub 2010 Oct 6.
- Background: PubMed 20223125Olivier Gomez C, Carballido Rodriguez J. [Circulating tumor cells: isolation, quantification, and relevance of their translation into clinical practice]. Actas Urol Esp. 2010 Jan;34(1):3-5. No abstract available. Spanish.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almudena Zapatero, MD, PhD, PI principal investigator
Radiation Oncology Department_Hospital Universitario de La Princesa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With High-risk Prostate Cancer, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Circulating Tumor Cells in the Peripheral Blood (time frame: Basal). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01800058, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.