Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis
This study is not yet open for participant recruitment.
Verified June 2012 by Hospices Civils de Lyon
Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01632930
First received: June 29, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
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Purpose
The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. In this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications.
The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is not covered by health insurance. It is therefore essential to assess the medical and economic impact of its introduction into medical practice.
We propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. Our working hypothesis is that the availability of the PCA3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.
| Condition | Intervention |
|---|---|
|
Patients Scheduled for Prostate Biopsy Because of Increased Serum PSA and/or Abnormal Digital Rectal Examination |
Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis |
Resource links provided by NLM:
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Proportion of patients who inappropriately underwent prostate biopsies (negative biopsy: no cancer) at end point [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Medical impact of availability of PCA3 test results [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine whether availability of PCA3 test results influences patient management in terms of physical examinations, , PSA testing, prostate ultrasonography, prostate MRI and delay in performing these tests
- Diagnostic performances of urinary PCA3 test [ Time Frame: 12, 24 and 60 months ] [ Designated as safety issue: No ]Intrinsic performances of PCA3 test in predicting prostate biopsy results in term of sensitivity, specificity and area under ROC curves
- Cost-efficiency study [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine how availability of PCA3 test results alters medical economics when managing patients with prostate cancer suspicion
| Estimated Enrollment: | 650 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Results of urinary PCA3 test will be available
In this arm, physicians will have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion is likely to be influenced by urinary PCA3 test results
|
Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account.
|
|
No Intervention: Results of urinary PCA3 test will not be available
In this arm, physicians will not have knowledge of urinary PCA3 test results. How they subsequently manage patients with prostate cancer suspicion will therefore not be influenced by urinary PCA3 test results
|
Other: urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)
urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account.
|
Eligibility| Ages Eligible for Study: | 18 Months and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients ≥ 18 year-old
- patients who undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination
- patients who gave informed consent
Exclusion Criteria:
- no informed consent
- medical history of or current significant prostate cancer
- medical history of or current extra-prostatic cancer
- high risk of loss of follow-up
- clinically obvious prostate cancer (clinical stage ≥ T3, PSA ≥ 50 ng/ml, lymph node involvement, osteolytic bone metastases)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632930
Contacts
| Contact: Virginie VLAEMINCK-GUILLEM, MD, PhD | 4 78 86 29 92 ext +33 | virginie.vlaeminck-guillem@chu-lyon.fr |
| Contact: Valérie Plattner | 4 72 11 52 13 ext +33 |
Locations
| France | |
| CHU Angers | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Rahmene AZZOUZI, Dr 2 41 35 35 18 ext +33 arazzouzi@chu-angers.fr | |
| Principal Investigator: Rahmene AZZOUZI, Dr | |
| Hôpital de la Cavale blanche | Not yet recruiting |
| Brest, France, 29609 | |
| Contact: Antoine VALERI, Pr 2 98 34 71 69 ext +33 Antoine.Valeri@univ-brest.fr | |
| Principal Investigator: Antoine VALERI, Pr | |
| Hôpital du Bocage | Not yet recruiting |
| Dijon, France, 21079 | |
| Contact: Luc CORMIER, Pr 3 80 29 35 80 ext +33 luc.cormier@chu-dijon.fr | |
| Principal Investigator: Luc CORMIER, Pr | |
| Hôpital Edouard Herriot | Not yet recruiting |
| Lyon, France | |
| Contact: Marc Marc COLOMBEL, Pr 4 72 11 91 91 ext +33 marc.colombel@chu-lyon.fr | |
| Principal Investigator: Marc COLOMBEL, Pr | |
| Hôpital Tenon | Not yet recruiting |
| Paris, France, 75020 | |
| Contact: Olivier CUSSENOT, Pr 1 56 01 64 95 ext +33 olivier.cussenot@tnn.aphp.fr | |
| Principal Investigator: Olivier CUSSENOT, Pr | |
| Hôpital Pitié-Salpêtrière, | Not yet recruiting |
| Paris, France, 75013 | |
| Contact: Marc Olivier BITKER, Pr 1 42 17 71 11 ext +33 mo.bitker@psl.aphp.fr | |
| Principal Investigator: Marc Olivier BITKER, Pr | |
| Centre Hospitalier Lyon Sud | Not yet recruiting |
| Pierre Benite, France, 69495 | |
| Contact: Alain RUFFION, Pr 4 72 67 88 09 ext +33 alain.ruffion@chu-lyon.fr | |
| Principal Investigator: Alain RUFFION, Pr | |
| Hôpital de la Milétrie | Not yet recruiting |
| Poitiers, France, 86000 | |
| Contact: Jacques IRANI, Pr 5 49 44 44 77 ext +33 j.irani@chu-poitiers.fr | |
| Principal Investigator: Jacques IRANI, Pr | |
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
No publications provided
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT01632930 History of Changes |
| Other Study ID Numbers: | 2011.660 |
| Study First Received: | June 29, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | France: The Commission nationale de l’informatique et des libertés France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Hospices Civils de Lyon:
|
diagnosis prostate cancer urine medical economics |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 13, 2013