Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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):
The quantification of CTC in blood samples will be done with the CellSearch® system. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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). | 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). | 9 - 12 months post-radiotherapy in cases with positivation after basal visit |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Failure-free Survival; | Phoenix criteria (PSA Nadir +2 ng/mL) | 4 years |
| Overall Survival | Defined as death due to any cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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))
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Almudena Zapatero, MD, PhD, PI | Radiation Oncology Department_Hospital Universitario de La Princesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Santiago de Compostela | Santiago de Compostela | La Coruña | 15706 | Spain | ||
| Hospital Universitario de La Princesa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18486743 | Background | Damber JE, Aus G. Prostate cancer. Lancet. 2008 May 17;371(9625):1710-21. doi: 10.1016/S0140-6736(08)60729-1. | |
| 18280056 | Background | Zelefsky 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. |
Not provided
Not provided
Not provided
66 patients included: 2 patients were not included in the final enrollment due to inegibility criteria
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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):
The quantification of CTC in blood samples will be done with the CellSearch® system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Basal |
|
4 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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):
The quantification of CTC in blood samples will be done with the CellSearch® system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative of colon volvulus | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Late urinary symptoms Grade >= 2 | Renal and urinary disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Almudena Zapatero, MD PhD | Hospital Universitario de La Princesa | +34 91 520 23 15 | almudena.zapatero@salud.madrid.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2012 | Jun 25, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Prospective analysis of biological material from samples of peripheral blood (PB) of patients with high risk prostate cancer treated with dose escalation RT combined with androgen deprivation (AD)
The sampling of PB for detection of CTCs was performed at 4 timepoints:
A cut off of 0 vs ≥ 1 CTC/7.5 mL blood was defined as a threshold for negative versus positive CTCs status.
| 4 years |
| Metastasis-free Survival | Defined as freedom from distant metastasis | 4 years |
| Cause Specific Survival | Defined as death caused by prostate cancer | 4 years |
| Madrid |
| 28006 |
| Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| 17765406 | Background | Kuban 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. |
| 18172188 | Background | Roach 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. |
| 18413638 | Background | Horwitz 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. |
| 17404082 | Background | Shaffer 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. |
| 17051950 | Background | Zapatero 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. |
| 15833514 | Background | Moreno 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. |
| 12114406 | Background | Fehm 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. |
| 18485578 | Background | Zapatero 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. |
| 20932659 | Background | Zapatero 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. |
| 20223125 | Background | Olivier 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. |
| 18698019 | Background | Alix-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. |
| 16488189 | Background | Mocellin 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. |
| 20427355 | Background | Cabanes 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. |
| 10959054 | Background | Ghossein RA, Bhattacharya S. Molecular detection and characterisation of circulating tumour cells and micrometastases in solid tumours. Eur J Cancer. 2000 Aug;36(13 Spec No):1681-94. doi: 10.1016/s0959-8049(00)00152-0. |
| 15897916 | Background | Llanes L, Ferruelo A, Lujan M, Pascual C, Garcia-Mediero JM, Berenguer A. Quantitative real-time reverse transcription: polymerase chain reaction of prostate-specific antigen (PSA) for detection of circulating prostatic cells in patients with clinically localized prostate cancer. Prostate Cancer Prostatic Dis. 2005;8(3):248-52. doi: 10.1038/sj.pcan.4500801. |
| 16170164 | Background | Zapatero A, Valcarcel F, Calvo FA, Algas R, Bejar A, Maldonado J, Villa S. Risk-adapted androgen deprivation and escalated three-dimensional conformal radiotherapy for prostate cancer: Does radiation dose influence outcome of patients treated with adjuvant androgen deprivation? A GICOR study. J Clin Oncol. 2005 Sep 20;23(27):6561-8. doi: 10.1200/JCO.2005.09.662. |
| 16798415 | Background | Roach M 3rd, Hanks G, Thames H Jr, Schellhammer P, Shipley WU, Sokol GH, Sandler H. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):965-74. doi: 10.1016/j.ijrobp.2006.04.029. |
| 16797376 | Background | Cristofanilli M. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. Semin Oncol. 2006 Jun;33(3 Suppl 9):S9-14. doi: 10.1053/j.seminoncol.2006.03.016. |
| Background | Bolla M, Collette L, Van Tienhoven G, et al. Ten-year results of long-term adjuvant androgen deprivation with goserelin in patients with locally advanced prostate cancer treated with radiotherapy: A phase III EORTC study. Int J Radiat Oncol Biol Phys 2008;72:S30-S31. |
| 20157216 | Background | Resel Folkersma L, Olivier Gomez C, San Jose Manso L, Veganzones de Castro S, Galante Romo I, Vidaurreta Lazaro M, de la Orden GV, Arroyo Fernandez M, Diaz Rubio E, Silmi Moyano A, Maestro de Las Casas MA. Immunomagnetic quantification of circulating tumoral cells in patients with prostate cancer: clinical and pathological correlation. Arch Esp Urol. 2010 Jan-Feb;63(1):23-31. |
| 32487218 | Result | Zapatero A, Gomez-Caamano A, Cabeza Rodriguez MA, Muinelo-Romay L, Martin de Vidales C, Abalo A, Calvo Crespo P, Leon Mateos L, Olivier C, Vega Piris LV. Detection and dynamics of circulating tumor cells in patients with high-risk prostate cancer treated with radiotherapy and hormones: a prospective phase II study. Radiat Oncol. 2020 Jun 1;15(1):137. doi: 10.1186/s13014-020-01577-5. |
| Result | A. Zapatero, A. Gomez Caamaño, M. D. L. A. Cabeza Rodriguez, L. Muinelo-Romay, C. Martin de Vidales C, A. Abalo, et al. Monitoring of Circulating Tumor Cells in Patients With High-Risk Nonmetastatic Prostate Cancer Treated With Radiation Therapy and Hormones: Preliminary Data of an Observational Prospective Phase 2 Study. International Journal of Radiation Oncology • Biology • Physics, Vol. 99, Issue 2, E280 |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Median PSA (ng/mL) | Median | Full Range | ng/mL |
|
| PSA pre-treatment | Count of Participants | Participants |
|
| Gleason score | Count of Participants | Participants |
|
| Clinical T Stage according to AJCC seventh edition | Count of Participants | Participants |
|
| Clinical N Stage according to AJCC seventh edition | Count of Participants | Participants |
|
| Radiotherapy dose (Gy) | Median | Full Range | Gy |
|
| Units | Counts |
|---|---|
| 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). | Posted | Count of Participants | Participants | Post-neoadjuvant hormone therapy and prior to radiotherapy |
|
|
|
| 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). | Posted | Count of Participants | Participants | Post-radiotherapy |
|
|
|
| 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). | Patients with positivation after basal visit | Posted | Count of Participants | Participants | 9 - 12 months post-radiotherapy in cases with positivation after basal visit |
|
|
|
| Secondary | Biochemical Failure-free Survival; | Phoenix criteria (PSA Nadir +2 ng/mL) | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Overall Survival | Defined as death due to any cause | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Metastasis-free Survival | Defined as freedom from distant metastasis | Posted | Count of Participants | Participants | 4 years |
|
|
|
| Secondary | Cause Specific Survival | Defined as death caused by prostate cancer | Posted | Count of Participants | Participants | 4 years |
|
|
|
| 7 |
| 65 |
| 7 |
| 65 |
| 15 |
| 65 |
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Head and neck cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Gastric adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Pneumomia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchoaspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastric GIST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Ureter cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Urethral estenosis | Renal and urinary disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Late rectal symptoms Grade >= 2 | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|