Randomized, Multicenter, Phase II Trial of Two Multicomponent Regimens in Androgen-Independent Prostate Cancer

2003 ◽  
Vol 21 (5) ◽  
pp. 878-883 ◽  
Author(s):  
Randall Millikan ◽  
Peter F. Thall ◽  
Sang-Joon Lee ◽  
Donnah Jones ◽  
M.W. Cannon ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Median Survival ◽  
Phase Ii ◽  
First Generation ◽  
Specific Antigen ◽  
Community Setting ◽  
Phase Iii ◽  
Group Setting ◽  
Clinically Significant ◽  
Androgen Independent

Purpose: Several multicomponent regimens have been reported to be useful in advanced androgen-independent prostate cancer. We used a randomized phase II design to evaluate and compare two such regimens. Patients were accrued primarily in the community setting. Patients and Methods: Patients with progressive, androgen-independent prostate cancer were randomly assigned to one of two treatments: either ketoconazole/doxorubicin alternating with vinblastine/estramustine (KA/VE) or paclitaxel, estramustine, and oral etoposide (TEE). Patients were prospectively stratified on the basis of disease volume. The primary end points were response and overall survival time. Results: A total of 75 patients were registered; 71 are included in the analysis. By the criterion of an 80% prostate-specific antigen reduction maintained for at least 8 weeks, 11 (30%) of 37 patients in the TEE arm responded, whereas 11 (32%) of 34 assigned to KA/VE responded. Median survival was 16.9 months (95% confidence interval [CI], 10.5 to 21.2 months) in the TEE arm and 23.4 months (95% CI, 12.9 to 30.6 months) for patients treated with KA/VE. Many patients (24%) failed to complete at least 6 weeks of therapy, including five (8%) treatment-related early deaths. Conclusion: Each of these regimens produced clinically significant responses, and the observed median survival (18.9 months for all 71 patients) compares favorably with previously published results, especially in the community setting. Nonetheless, it is apparent that these first-generation regimens must be applied judiciously, and thus we view efforts at better patient selection and the development of more tolerable therapies as higher priorities than carrying either of these regimens to phase III evaluation in the cooperative group setting.

Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial

2018 ◽  
Vol 36 (5) ◽  
pp. 446-453 ◽  
Author(s):  
Piet Ost ◽  
Dries Reynders ◽  
Karel Decaestecker ◽  
Valérie Fonteyne ◽  
Nicolaas Lumen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Specific Antigen ◽  
Phase Iii ◽  
Curative Intent ◽  
Free Survival ◽  
Local Progression ◽  
Randomized Phase Ii

Purpose Retrospective studies suggest that metastasis-directed therapy (MDT) for oligorecurrent prostate cancer (PCa) improves progression-free survival. We aimed to assess the benefit of MDT in a randomized phase II trial. Patients and Methods In this multicenter, randomized, phase II study, patients with asymptomatic PCa were eligible if they had had a biochemical recurrence after primary PCa treatment with curative intent, three or fewer extracranial metastatic lesions on choline positron emission tomography–computed tomography, and serum testosterone levels > 50 ng/mL. Patients were randomly assigned (1:1) to either surveillance or MDT of all detected lesions (surgery or stereotactic body radiotherapy). Surveillance was performed with prostate-specific antigen (PSA) follow-up every 3 months, with repeated imaging at PSA progression or clinical suspicion for progression. Random assignment was balanced dynamically on the basis of two factors: PSA doubling time (≤ 3 v > 3 months) and nodal versus non-nodal metastases. The primary end point was androgen deprivation therapy (ADT)–free survival. ADT was started at symptomatic progression, progression to more than three metastases, or local progression of known metastases. Results Between August 2012 and August 2015, 62 patients were enrolled. At a median follow-up time of 3 years (interquartile range, 2.3-3.75 years), the median ADT-free survival was 13 months (80% CI, 12 to 17 months) for the surveillance group and 21 months (80% CI, 14 to 29 months) for the MDT group (hazard ratio, 0.60 [80% CI, 0.40 to 0.90]; log-rank P = .11). Quality of life was similar between arms at baseline and remained comparable at 3-month and 1-year follow-up. Six patients developed grade 1 toxicity in the MDT arm. No grade 2 to 5 toxicity was observed. Conclusion ADT-free survival was longer with MDT than with surveillance alone for oligorecurrent PCa, suggesting that MDT should be explored further in phase III trials.

Eligibility and Response Guidelines for Phase II Clinical Trials in Androgen-Independent Prostate Cancer: Recommendations From the Prostate-Specific Antigen Working Group

1999 ◽  
Vol 17 (11) ◽  
pp. 3461-3467 ◽  
Author(s):  
Glenn J. Bubley ◽  
Michael Carducci ◽  
William Dahut ◽  
Nancy Dawson ◽  
Danai Daliani ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Prostate Specific Antigen ◽  
Phase Ii ◽  
Metastatic Disease ◽  
Specific Antigen ◽  
Consensus Conference ◽  
End Point ◽  
Phase Ii Clinical Trials ◽  
Androgen Independent

PURPOSE: Prostate-specific antigen (PSA) is a glycoprotein that is found almost exclusively in normal and neoplastic prostate cells. For patients with metastatic disease, changes in PSA will often antedate changes in bone scan. Furthermore, many but not all investigators have observed an association between a decline in PSA levels of 50% or greater and survival. Since the majority of phase II clinical trials for patients with androgen-independent prostate cancer (AIPC) have used PSA as a marker, we believed it was important for investigators to agree on definitions and values for a minimum set of parameters for eligibility and PSA declines and to develop a common approach to outcome analysis and reporting. We held a consensus conference with 26 leading investigators in the field of AIPC to define these parameters. RESULT: We defined four patient groups: (1) progressive measurable disease, (2) progressive bone metastasis, (3) stable metastases and a rising PSA, and (4) rising PSA and no other evidence of metastatic disease. The purpose of determining the number of patients whose PSA level drops in a phase II trial of AIPC is to guide the selection of agents for further testing and phase III trials. We propose that investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period. Some investigators may want to report additional measures of PSA changes (ie, 75% decline, 90% decline). Response duration and the time to PSA progression may also be important clinical end point. CONCLUSION: Through this consensus conference, we believe we have developed practical guidelines for using PSA as a measurement of outcome. Furthermore, the use of common standards is important as we determine which agents should progress to randomized trials which will use survival as an end point.

Prospective, Multicenter, Randomized Phase II Trial of the Herbal Supplement, PC-SPES, and Diethylstilbestrol in Patients With Androgen-Independent Prostate Cancer

2004 ◽  
Vol 22 (18) ◽  
pp. 3705-3712 ◽  
Author(s):  
William K. Oh ◽  
Philip W. Kantoff ◽  
Vivian Weinberg ◽  
Graham Jones ◽  
Brian I. Rini ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Phase Ii ◽  
Ethinyl Estradiol ◽  
Specific Antigen ◽  
Response Duration ◽  
Herbal Supplement ◽  
Median Response ◽  
Randomized Phase Ii ◽  
Androgen Independent

Purpose To evaluate the herbal combination, PC-SPES, and diethylstilbestrol (DES) in patients with androgen independent prostate cancer (AIPC). Patients and Methods A randomized phase II study was conducted with cross-over design. Patients were randomly assigned to receive either three PC-SPES capsules orally three times a day or DES 3 mg orally once a day. Prophylactic warfarin was administered. At clinical or prostate-specific antigen progression, patients received the other therapy. The study closed prematurely after PC-SPES was withdrawn from the market. Chemical analyses were performed on multiple lots of PC-SPES. Results Ninety patients were enrolled, of whom 85 were assessable for response. Prostate-specific antigen declines ≥ 50% were noted in 40% (95% CI, 25% to 56%) with PC-SPES, and 24% (95% CI, 12% to 39%) with DES. Median response duration was not reached with PC-SPES, and was 3.8 months with DES. Median time to progression for randomly assigned patients was 5.5 months for PC-SPES and 2.9 months for DES. Common toxicities included mild fatigue, gynecomastia, and mastodynia. Five thromboembolic events occurred (one PC-SPES, four DES). Responses in the cross-over phase were inconclusive. Four lots of PC-SPES had measurable quantities of DES, ranging from 0.01% to 3.1% of the dose used in the DES arm. Ethinyl estradiol was also detected in PC-SPES lots. Conclusion PC-SPES and DES demonstrate activity in AIPC and are well tolerated. However, the synthetic estrogens, DES and ethinyl estradiol, were detected in various lots of PC-SPES, including those used in this trial. Clinical trials that utilize herbal therapies must account for issues of purity and consistency.

scholarly journals Overall Survival Analysis of a Phase II Randomized Controlled Trial of a Poxviral-Based PSA-Targeted Immunotherapy in Metastatic Castration-Resistant Prostate Cancer

2010 ◽  
Vol 28 (7) ◽  
pp. 1099-1105 ◽  
Author(s):  
Philip W. Kantoff ◽  
Thomas J. Schuetz ◽  
Brent A. Blumenstein ◽  
L. Michael Glode ◽  
David L. Bilhartz ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Phase Ii ◽  
Viral Vectors ◽  
Controlled Trial ◽  
Specific Antigen ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Randomized Controlled ◽  
Castration Resistant

PurposeTherapeutic prostate-specific antigen (PSA) –targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study.Patients and MethodsIn total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections.ResultsEighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061.ConclusionPROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study.

scholarly journals Significant and Sustained Antitumor Activity in Post-Docetaxel, Castration-Resistant Prostate Cancer With the CYP17 Inhibitor Abiraterone Acetate

2010 ◽  
Vol 28 (9) ◽  
pp. 1489-1495 ◽  
Author(s):  
Alison H.M. Reid ◽  
Gerhardt Attard ◽  
Daniel C. Danila ◽  
Nikhil Babu Oommen ◽  
David Olmos ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Antitumor Activity ◽  
Phase Ii ◽  
Specific Antigen ◽  
Abiraterone Acetate ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
End Point ◽  
Castration Resistant ◽  
Psa Progression

Purpose The principal objective of this trial was to evaluate the antitumor activity of abiraterone acetate, an oral, specific, irreversible inhibitor of CYP17 in docetaxel-treated patients with castration-resistant prostate cancer (CRPC). Patients and Methods In this multicenter, two-stage, phase II study, abiraterone acetate 1,000 mg was administered once daily continuously. The primary end point was achievement of a prostate-specific antigen (PSA) decline of ≥ 50% in at least seven of 35 patients. Per an attained phase II design, more than 35 patients could be enrolled if the primary end point was met. Secondary objectives included: PSA declines of ≥ 30% and ≥ 90%; rate of RECIST (Response Evaluation Criteria in Solid Tumors) responses and duration on study; time to PSA progression; safety and tolerability; and circulating tumor cell (CTC) enumeration. Results Docetaxel-treated patients with CRPC (N = 47) were enrolled. PSA declines of ≥ 30%, ≥ 50% and ≥ 90% were seen in 68% (32 of 47), 51% (24 of 47), and 15% (seven of 47) of patients, respectively. Partial responses (by RECIST) were reported in eight (27%) of 30 patients with measurable disease. Median time to PSA progression was 169 days (95% CI, 113 to 281 days). The median number of weeks on study was 24, and 12 (25.5%) of 47 patients remained on study ≥ 48 weeks. CTCs were enumerated in 34 patients; 27 (79%) of 34 patients had at least five CTCs at baseline. Eleven (41%) of 27 patients had a decline from at least five to less than 5 CTCs, and 18 (67%) of 27 had a ≥ 30% decline in CTCs after starting treatment with abiraterone acetate. Abiraterone acetate was well tolerated. Conclusion Abiraterone acetate has significant antitumor activity in post-docetaxel patients with CRPC. Randomized, phase III trials of abiraterone acetate are underway to define the future role of this agent.

Antiandrogen Withdrawal Alone or in Combination With Ketoconazole in Androgen-Independent Prostate Cancer Patients: A Phase III Trial (CALGB 9583)

2004 ◽  
Vol 22 (6) ◽  
pp. 1025-1033 ◽  
Author(s):  
Eric J. Small ◽  
Susan Halabi ◽  
Nancy A. Dawson ◽  
Walter M. Stadler ◽  
Brian I. Rini ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Progressive Disease ◽  
Specific Antigen ◽  
Phase Iii ◽  
Adrenal Androgen ◽  
Phase Iii Trial ◽  
Androgen Ablation ◽  
Psa Response ◽  
Androgen Levels ◽  
Androgen Independent

Purpose Antiandrogen withdrawal (AAWD) results in a prostate-specific antigen (PSA) response (decline in PSA level of ≥ 50%) in 15% to 30% of androgen-independent prostate cancer (AiPCa) patients. Thereafter, adrenal androgen ablation with agents such as ketoconazole (K) is commonly utilized. The therapeutic effect of AAWD alone was compared with simultaneous AAWD and K therapy. Patients and Methods AiPCa patients were randomized to undergo AAWD alone (n = 132), or together with K (400 mg orally [po] tid) and hydrocortisone (30 mg po each morning, 10 mg po each evening; n = 128). Patients who developed progressive disease after AAWD alone were eligible for deferred treatment with K. Results Eleven percent of patients undergoing AAWD alone had a PSA response, compared to 27% of patients who underwent AAWD and simultaneous K (P = .0002). Objective responses were observed in 2% of patients treated with AAWD alone compared to 20% in patients treated with AAWD/K (P = .02). There was no difference in survival. PSA and objective responses were observed in 32% and 7%, respectively, of patients receiving deferred K, and were more common in patients with prior AAWD response. Treatment with K was well tolerated, and resulted in a decline in adrenal androgen levels, which rose at the time of disease progression. Conclusion K has modest activity in AiPCa patients, while AAWD alone has minimal activity. Adrenal androgen levels fall with treatment with K and then climb at the time of progression, suggesting that progressive disease while on K may be due to tachyphylaxis to the adrenolytic properties of K.

Phase II study of ketoconazole combined with weekly doxorubicin in patients with androgen-independent prostate cancer.

1994 ◽  
Vol 12 (4) ◽  
pp. 683-688 ◽  
Author(s):  
A Sella ◽  
R Kilbourn ◽  
R Amato ◽  
C Bui ◽  
A A Zukiwski ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Antitumor Activity ◽  
Adrenal Insufficiency ◽  
Phase Ii ◽  
Specific Antigen ◽  
Cardiac Complications ◽  
Acral Erythema ◽  
Psa Response ◽  
Grade Iii ◽  
Androgen Independent

PURPOSE A phase II clinical trial was performed to assess the antitumor activity and toxicity of ketoconazole in combination with doxorubicin (Adriamycin; Adria Laboratories, Columbus, OH) in patients with androgen-independent prostate cancer (AI PCa). PATIENTS AND METHODS Thirty-nine consecutive patients whose disease progressed following castration were treated with oral ketoconazole (1,200 mg) daily and Adriamycin (20 mg/m2 in a 24-hour infusion) once weekly. Antitumor activity was assessed by the level of prostatic-specific antigen (PSA) decline. RESULTS PSA levels decreased > or = 50% from baseline in 21 (55%; 95% confidence interval, 38% to 71%) of 38 assessable patients. We observed partial responses (PRs) in seven (58%) of 12 patients with measurable soft tissue disease (in the lung, lymph nodes, and liver). Two patients with history of atherosclerotic heart disease had a sudden cardiac death. Serious toxic reactions included grade III to V stomatitis and grade III to IV acral erythema in 11 patients (29%), and grade III to IV anal and urethral mucositis in five patients (13%). Grade III to IV neutropenia occurred in 11 patients (29%). Seventeen patients (45%) required hospitalization for complications. Fifteen patients (39%) developed hypokalemia, and 24 patients (63%) developed clinical adrenal insufficiency. CONCLUSION The combination of ketoconazole and Adriamycin has a 55% PSA response rate in patients with AI PCa and is worthy of additional study. This treatment results in frequent adrenal insufficiency. Therefore, future studies should incorporate routine corticosteroid replacement. The cardiac complications caused by this combination should be studied further before it is widely used.

scholarly journals Analysis of risk factors for determining the need for prostate biopsy in patients with negative MRI

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Linghui Liang ◽  
Feng Qi ◽  
Yifei Cheng ◽  
Lei Zhang ◽  
Dongliang Cao ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Detection Efficiency ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Multivariable Logistic Regression Analysis ◽  
Detection Rates ◽  
Prostate Biopsies ◽  
Clinically Significant ◽  
Definition Of ◽  
Medical University

AbstractTo analyze the clinical characteristics of patients with negative biparametric magnetic resonance imaging (bpMRI) who didn’t need prostate biopsies (PBs). A total of 1,012 male patients who underwent PBs in the First Affiliated Hospital of Nanjing Medical University from March 2018 to November 2019, of 225 had prebiopsy negative bpMRI (defined as Prostate Imaging Reporting and Data System (PI-RADS 2.1) score less than 3). The detection efficiency of clinically significant prostate cancer (CSPCa) was assessed according to age, digital rectal examination (DRE), prostate volume (PV) on bpMRI, prostate-specific antigen (PSA) and PSA density (PSAD). The definition of CSPCa for Gleason score > 6. Univariate and multivariable logistic regression analysis were used to identify predictive factors of absent CSPCa on PBs. Moreover, absent CSPCa contained clinically insignificant prostate cancer (CIPCa) and benign result. The detection rates of present prostate cancer (PCa) and CSPCa were 27.11% and 16.44%, respectively. Patients who were diagnosed as CSPCa had an older age (P < 0.001), suspicious DRE (P < 0.001), a smaller PV (P < 0.001), higher PSA value (P = 0.008) and higher PSAD (P < 0.001) compared to the CIPCa group and benign result group. PSAD < 0.15 ng/ml/cm3 (P = 0.004) and suspicious DRE (P < 0.001) were independent predictors of absent CSPCa on BPs. The negative forecast value of bpMRI for BP detection of CSPCa increased with decreasing PSAD, mainly in patients with naive PB (P < 0.001) but not in prior negative PB patients. 25.33% of the men had the combination of negative bpMRI, PSAD < 0.15 ng/ml/cm3 and PB naive, and none had CSPCa on repeat PBs. The incidence of PB was determined, CSPCa was 1.59%, 0% and 16.67% in patients with negative bpMRI and PSAD < 0.15 ng/ml/cm3, patients with negative bpMRI, PSAD < 0.15 ng/ml/cm3 and biopsy naive and patients with negative bpMRI, PSAD < 0.15 ng/ml/cm3 and prior negative PB, separately. We found that a part of patients with negative bpMRI, a younger age, no suspicious DRE and PSAD < 0.15 ng/ml/cm3 may securely avoid PBs. Conversely PB should be considered in patients regardless of negative bpMRI, especially who with a greater age, obviously suspicious DRE, significantly increased PSA value, a significantly small PV on MRI and PSAD > 0.15 ng/ml/cm3.

scholarly journals A randomized phase II study of concurrent docetaxel plus vaccine versus vaccine alone in metastatic androgen-independent prostate cancer.

2006 ◽  
Vol 12 (4) ◽  
pp. 1260-1269 ◽  
Author(s):  
Philip M Arlen ◽  
James L Gulley ◽  
Catherine Parker ◽  
Lisa Skarupa ◽  
Mary Pazdur ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Randomized Phase Ii ◽  
Androgen Independent

scholarly journals Who’s too old to screen? Prostate cancer in elderly men

2013 ◽  
Vol 3 (3) ◽  
pp. 205 ◽  
Author(s):  
Sandeep Mistry ◽  
Wesley Mayer ◽  
Rose Khavari ◽  
Gustavo Ayala ◽  
Brian Miles
Keyword(s):  
Prostate Cancer ◽  
Specific Antigen ◽  
Threshold Value ◽  
The Elderly ◽  
Cancer De La Prostate ◽  
Gleason Grade ◽  
Elderly Men ◽  
Patients Âgés ◽  
Positive Core ◽  
Clinically Significant

Introduction: Prostate cancer is the most common nonskin malignancyaffecting men and is the second leading cause of cancerrelateddeath in North America. The incidence of prostate cancerincreases dramatically with age. However, many healthauthorities advocate the cessation of routine prostate cancer testingin men older than 75 because of the belief that most patientswill have a clinically insignificant cancer and will not benefit fromtherapy. The true prevalence of clinically significant prostate cancerin elderly men is not known.Methods: We analyzed 1446 needle biopsies of the prostate inmen aged 75 or older. All pathological reviews were conductedby the pathology department at the Methodist Hospital in Houston,Tex. Data were collected from pathology reports, hospital andclinic databases, and medical records when available. Dataobtained included age at biopsy, serum prostate-specific antigen(PSA) levels, number of positive core biopsies and Gleasongrade. Statistical analysis was performed using Stata. Clinicallysignificant cancer was defined by the pathological presence ofGleason grade 6 adenocarcinoma in more than 1 biopsy coreor the presence of any Gleason 4 or 5 component in the biopsy.Results: The median age of the patients included in the studywas 78.8 and 95% of the patients were between the ages of 75and 85. The mean serum PSA level for patients biopsied was10.4 μg/L. Of all biopsies reviewed, 53% were positive for prostatecancer and 78% of these would be defined as clinically significantcancer. Regression analysis revealed age to be a significant(p < 0.05) factor for increased Gleason grade in positive biopsies.Logistic regression revealed age as a significant factor (p <0.05) for clinically significant prostate cancer even when controllingfor PSA. A serum PSA threshold value of 6.5 μg/L would havemissed 38% of significant cancers and a threshold of 4.0 μg/Lwould have missed 8% of significant cancers.Conclusion: Our findings suggest that the prevalence of clinicallysignificant prostate cancer in the elderly population may be higherthan previously thought. As the population continues to livelonger and healthier lives, it will become more common to confrontprostate cancer morbidity in the eldery population. Usinghigher serum PSA thresholds to eliminate unnecessary biopsies inolder men does not appear to help identify patients at greaterrisk of having clinically significant prostate cancer. Patients withprostate cancer having aggressive clinical features may benefitfrom treatment of their prostate cancer well into their eighth andninth decades of life. Testing and diagnostic recommendationsshould reflect the potential benefit of identifying patients withaggressive prostate cancer even after age 75.Introduction : Le cancer de la prostate est le type de cancer noncutané le plus fréquent chez les hommes et la seconde causede décès lié au cancer en importance en Amérique du Nord.L’incidence du cancer de la prostate augmente grandement avecl’âge. Néanmoins, de nombreuses autorités en matière de santéavancent l’idée de mettre fin au dépistage systématique du cancerde la prostate chez les hommes de plus de 75 ans en raisonde la croyance selon laquelle la plupart des patients présenterontun cancer non significatif sur le plan clinique et ne bénéficierontpas d’un traitement. La véritable prévalence des cas decancer de la prostate cliniquement significatif chez les hommesâgés n’est pas établie.Méthodes : Nous avons analysé 1446 échantillons de biopsie àl’aiguille prélevés au niveau de la prostate chez des patients de75 ans ou plus. Toutes les analyses de pathologie ont été effectuéespar le service de pathologie du Methodist Hospital deHouston, au Texas. Les données ont été tirées des rapports depathologie, des bases de données des hôpitaux et des cliniques,et des dossiers médicaux lorsque possible. Les données obtenuesincluaient l’âge au moment de la biopsie, les valeurs d’antigèneprostatique spécifique (APS), le nombre de microbiopsies positiveset le score de Gleason. Les analyses statistiques ont été effectuéesà l’aide du système Stata. Le cancer cliniquement significatifest défini comme la présence d’un adénocarcinome avec un scorede Gleason de 6 dans plus d’une zone de biopsie ou un scorede Gleason de 4 ou 5 dans toute partie de l’échantillon.Résultats : L’âge moyen des patients inclus était de 78,8 ans et95 % des patients avaient entre 75 et 85 ans. La valeur moyennede l’APS chez les patients ayant subi une biopsie était de 10,4 μg/L.De tous les échantillons examinés, 53 % confirmaient la présenced’un cancer de la prostate, et le cancer était défini comme étantcliniquement significatif dans 78 % de ces cas. Une analyse derégression a révélé que l’âge était un facteur significatif (p <0,05) lié à un score de Gleason plus élevé dans les biopsies positives.Une analyse de régression logistique a révélé que l’âge étaitaussi un facteur significatif (p < 0,05) lié à un cancer de la prostatecliniquement significatif même en tenant compte du taux d’APS.Une valeur seuil d’APS de 6,5 μg/L serait passée à côté de 38 %des cas de cancer significatif, alors qu’une valeur seuil d’APSde 4,0 μg/L serait passée à côté de 8 % des cancers significatifs.Conclusion : Nos observations portent à croire que la prévalencedu cancer de la prostate significatif sur le plan clinique chezles patients âgés pourrait être plus élevée qu’on le croit. Avecl’augmentation de l’espérance de vie, l’incidence de la morbiditéliée au cancer de la prostate augmentera. Le recours àdes valeurs seuils d’APS plus élevées pour éliminer les cas debiopsies non nécessaires chez les hommes âgés ne semble pasaider à cerner les patients présentant un risque plus élevé de cancerde la prostate cliniquement significatif. Les patients atteintsde cancer de la prostate cliniquement agressif peuvent bénéficierd’un traitement contre le cancer même lorsqu’ils dépassentlargement les 80 ou les 90 ans. Les recommandations concernantle dépistage et le diagnostic devraient refléter les avantages potentielsliés au dépistage d’un cancer de la prostate agressif, mêmeaprès 75 ans.

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