Prospective evaluation of a “Watchful Waiting” program using initial pathology criteria and PSA-doubling time monitoring for patients with stage T1c prostate cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14651-14651
Author(s):  
Y. Kakehi ◽  
T. Kamoto ◽  
O. Ogawa ◽  
K. Tobisu ◽  
Y. Saito ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Doubling Time ◽  
Watchful Waiting ◽  
Point Estimate ◽  
Aggressive Treatment ◽  
Eligibility Criteria ◽  
Psa Doubling Time ◽  
Early Dropout ◽  
Positive Core

14651 Background: “Watchful waiting (WW)” is becoming a common treatment option for patients (pts) with screening detected prostate cancer. There is, however, no consensus about which pts are suitable for WW and how pts are monitored. Methods: Eligibility criteria: 1) stage T1c prostate cancer pts, 2) age 50–80, 3) serum PSA: 20 ng/ml or less, 4) 1 or 2 positive cores per 6 to 12 systematic core biopsies, 5) Gleason score of 6 or less, 6) 50% or less maximum % cancer occupation in a positive core. The criteria of 4), 5), 6) were confirmed by a central pathologist before pts registration. Registered patients chose either WW or immediate aggressive treatment. In patients who chose WW, serum PSA was monitored every 2 months for 6 months and PSA-doubling time (PSADT) was calculated centrally. Those who showed PSADT 2y and re-biopsy at 13 months fit the initial pathology criteria again. Primary endpoint was “% PSADT > 2 y”, which was defined as proportion of patients who showed PSADT at 6 months > 2 y out of all patients who chose WW. Point estimate of “% PSADT > 2 y” was expected to be higher than 80%. The planned sample size was 100 pts who chose WW, which gives the width of 95% confidence intervals for % PSADT > 2 y within 10%. Results: 134 pts were enrolled from 01/2002 to 12/2003 and 118 pts chose WW while 13 pts chose aggressive treatment (surgery, radiotherapy, hormonal therapy). The initial 6 months’ PSADT could be assessed in 106 patients (measurement point error in 6, early dropout in 6). Of 106 patients, 22 showed PSADT < 2 y (“rapid riser”) while 84 showed PSADT > 2 y. “% PSADT > 2 y” was 71.2% (84/118, 95% CI: 62.1–79.2%). 84 pts have continued WW with median follow-up of 27 months. Neither metastasis nor cancer-death was observed until 06/2005. As to health-related QOL, any domain of SF-36 was not impaired in patients who continued WW at least for 1 year. Conclusion: Our initial selection criteria for WW may include at least 20% of “rapid riser”, hence need further modification. Additionally, it should be confirmed by further follow-up of 84 pts whether eliminating “rapid riser” from WW by initial 6 months’ PSADT is appropriate. No significant financial relationships to disclose.

665: Baseline PSA and PSA Doubling Time Predict the Risk of Objective Progression and Death in Patients with T0-4 N0-2 M0 Prostate Cancer on Watchful Waiting

2006 ◽  
Vol 175 (4S) ◽  
pp. 215-215 ◽  
Author(s):  
Urs E. Studer ◽  
Laurence Collette ◽  
Peter Whelan ◽  
Walter Albrecht ◽  
Jacques Casselman ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Doubling Time ◽  
Watchful Waiting ◽  
Psa Doubling Time ◽  
Baseline Psa

Utility of PSA doubling time in follow-up of untreated patients with localized prostate cancer

Urology ◽  
2002 ◽  
Vol 59 (5) ◽  
pp. 652-656 ◽  
Author(s):  
Andrew J Stephenson ◽  
Armen G Aprikian ◽  
Luis Souhami ◽  
Hassan Behlouli ◽  
Avrum I Jacobson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Doubling Time ◽  
Localized Prostate Cancer ◽  
Psa Doubling Time

Role of 5-alpha-reductase inhibitors in active surveillance of patients with low-risk prostate cancer.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 14-14
Author(s):  
Andrew Szehsun Chiang ◽  
D. Andrew Loblaw ◽  
Vibhuti Jethava ◽  
Perakaa Sethukavalan ◽  
Liying Zhang ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Doubling Time ◽  
Low Risk ◽  
Reductase Inhibitors ◽  
Psa Doubling Time ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer ◽  
5 Alpha Reductase Inhibitors ◽  
Doubling Times

14 Background: Active surveillance (AS) is a recognized management option for low-risk prostate cancer. Many institutions use serial PSA values to determine when to reclassify patients into higher risk categories. The impact of 5-alpha-reductase inhibitors (5-ARIs) in this setting has not been well studied. The purpose of this retrospective review was to compare PSA doubling time prior to the initiation of a 5-ARI (pre-5-ARI) to that after the PSA nadir (post-nadir) has been reached. Methods: Between 1996 and 2010, a total of 100 patients with a history of 5-ARI use were captured from our AS database. Of these, twenty-nine had a sufficient number of PSA values to determine both pre-5-ARI and post-nadir doubling times. The majority had stage T1c disease (89.7%) and Gleason scores of six or lower (93.1%). The average PSA at presentation was 6.93 µg/L. More patients were prescribed dutasteride (79.3%) than finasteride (20.7%). PSA doubling time was calculated using the general linear mixed-model method. Statistical analysis was performed using the non-parametric sign test. Results: Median follow-up was 69.5 months (mo). For the twenty-nine patients analyzed, the median pre-5-ARI PSA doubling time was 55.8 mo (6-556.8 mo), while that for the post-nadir values was 25.2 mo (6-231 mo) (p=0.0081). Six patients were ultimately reclassified after an average of 67.7 mo (59-95 mo), due to progression in either PSA doubling time (n=2) or Gleason score (n=4). The median pre-5-ARI and post-nadir doubling times for this group were 48.2 mo (32.4-91.1 mo) and 23.3 mo (6-44.3 mo), respectively. Five of the patients underwent radical prostatectomy, while one underwent radiotherapy with androgen deprivation. Of the six patients, one had biochemical failure after an average post-treatment follow-up of 21.3 mo (0-52 mo). Conclusions: In AS for low-risk prostate cancer, it was found that 5-ARIs significantly decreased PSA doubling time. This effect may be related to preferential suppression of benign prostatic tissue, thereby providing a more accurate depiction of the true cancer-related doubling time. If validated with a larger cohort, 5-ARIs may enhance the utility of PSA doubling time as a biomarker of disease progression in AS.

LONG TERM FOLLOW UP OF PHASE 2 STUDY OF POMEGRANATE JUICE FOR MEN WITH PROSTATE CANCER SHOWS DURABLE PROLONGATION OF PSA DOUBLING TIME

2009 ◽  
Vol 181 (4S) ◽  
pp. 295-295 ◽  
Author(s):  
Allan J Pantuck ◽  
Nazy Zomorodian ◽  
Matthew Rettig ◽  
William J Aronson ◽  
David Heber ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Doubling Time ◽  
Pomegranate Juice ◽  
Phase 2 ◽  
Psa Doubling Time ◽  
Phase 2 Study ◽  
Long Term Follow Up

Impact of comorbidity and PSA doubling time on the risk of death in men experiencing PSA failure following radiation therapy with or without androgen deprivation therapy for unfavorable-risk prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 68-68
Author(s):  
Sagar Anil Patel ◽  
Ming-Hui Chen ◽  
Marian Loffredo ◽  
Andrew A. Renshaw ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radiation Therapy ◽  
Androgen Deprivation Therapy ◽  
Doubling Time ◽  
Androgen Deprivation ◽  
Psa Doubling Time ◽  
Psa Failure ◽  
Severe Comorbidity ◽  
The Impact

68 Background: The optimal management of men with PSA failure following initial prostate cancer therapy based on comorbidity is unknown. We investigated the impact that PSA doubling time (DT) and comorbidity had on the risk of all cause (AC), prostate cancer-specific (PCS) and other cause mortality (OCM) following PSA failure. Methods: Between 1995 and 2001, 206 men with unfavorable-risk PC were randomized to receive radiation therapy alone or in combination with 6 months of androgen deprivation therapy (ADT). After a median follow up of 16.2 years, 108 men experienced PSA failure (85, no or minimal; 23, moderate to severe comorbidity) and formed the study cohort. Cox and Fine-Gray regression analysis was used to determine whether PSA DT was associated with the risk of ACM and PCSM/OCM respectively, stratified by ACE-27 comorbidity score. Results: After a median follow up of 13.71 years following PSA failure, 81 of the 108 men (75%) died. Longer PSA DT was associated with a decreased risk of PCSM in men with no/minimal (AHR 0.33, 95% CI 0.17-0.65, p= 0.001) and moderate/severe comorbidity (AHR 0.014, 95% CI 0.002-0.129, p= 0.0002) with a trend toward an increased risk of OCM in men with no/minimal (AHR 1.42, 95% CI 0.94-2.16, p= 0.10) and moderate/severe comorbidity (AHR 1.68, 95% CI 0.85-3.35, p= 0.14). However, increasing PSA DT was only associated with a decreased risk of ACM in men with no/minimal (AHR 0.69, 95% CI 0.50-0.96, p = 0.03) but not moderate/severe comorbidity (AHR 0.95, 95% CI 0.51-1.78, p= 0.87). Conclusions: The extent and natural history of comorbidity as well as PSA DT should be taken into consideration when deciding on appropriate management and/or clinical trial eligibility at the time of PSA failure. Specifically, randomized studies are needed to determine whether survival is prolonged in men with life-shortening comorbidity with salvage ADT at the time of PSA failure versus surveillance and reserving ADT use for symptomatic progression. For all other men, trials comparing ADT with or without novel agents shown to prolong survival in men with metastatic castrate resistant PC is warranted.

Clinical Results of Long-Term Follow-Up of a Large, Active Surveillance Cohort With Localized Prostate Cancer

2010 ◽  
Vol 28 (1) ◽  
pp. 126-131 ◽  
Author(s):  
Laurence Klotz ◽  
Liying Zhang ◽  
Adam Lam ◽  
Robert Nam ◽  
Alexandre Mamedov ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Cancer Mortality ◽  
Doubling Time ◽  
Localized Prostate Cancer ◽  
Definitive Treatment ◽  
Prostate Cancer Mortality ◽  
Psa Doubling Time ◽  
Psa Failure

Purpose We assessed the outcome of a watchful-waiting protocol with selective delayed intervention by using clinical prostate-specific antigen (PSA), or histologic progression as treatment indications for clinically localized prostate cancer. Patients and Methods This was a prospective, single-arm, cohort study. Patients were managed with an initial expectant approach. Definitive intervention was offered to those patients with a PSA doubling time of less than 3 years, Gleason score progression (to 4 + 3 or greater), or unequivocal clinical progression. Survival analysis and Cox proportional hazard model were applied to the data. Results A total of 450 patients have been observed with active surveillance. Median follow-up was 6.8 years (range, 1 to 13 years). Overall survival was 78.6%. The 10-year prostate cancer actuarial survival was 97.2%. Overall, 30% of patients have been reclassified as higher risk and have been offered definitive therapy. Of 117 patients treated radically, the PSA failure rate was 50%, which was 13% of the total cohort. PSA doubling time of 3 years or less was associated with an 8.5-times higher risk of biochemical failure after definitive treatment compared with a doubling time of more than 3 years (P < .0001). The hazard ratio for nonprostate cancer to prostate cancer mortality was 18.6 at 10 years. Conclusion We observed a low rate of prostate cancer mortality. Among the patients who were reclassified as higher risk and who were treated, PSA failure was relatively common. Other-cause mortality accounted for almost all of the deaths. Additional studies are warranted to improve the identification of patients who harbor more aggressive disease despite favorable clinical parameters at diagnosis.

Variations in PSA doubling time in patients with prostate cancer on “watchful waiting”: Value of short-term PSADT determinations

Urology ◽  
2004 ◽  
Vol 64 (2) ◽  
pp. 323-328 ◽  
Author(s):  
Phillip L Ross ◽  
Salaheddin Mahmud ◽  
Andrew J Stephenson ◽  
Luis Souhami ◽  
Simon Tanguay ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Doubling Time ◽  
Watchful Waiting ◽  
Short Term ◽  
Psa Doubling Time
Sign in / Sign up

Export Citation Format

Share Document