Using PSA to Guide Timing of Androgen Deprivation in Patients with T0–4 N0–2 M0 Prostate Cancer not Suitable for Local Curative Treatment (EORTC 30891)

Studer, Urs E.; Collette, Laurence; Whelan, Peter; Albrecht, Walter; Casselman, J; Reijke, Theo de; Knönagel, H; Loidl, Wolfgang; Isorna, Santiago; Sundaram, S.K.; Debois, Muriel

doi:10.1016/j.eururo.2007.12.032

Cited by 136 publications

(69 citation statements)

References 12 publications

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“…Because the optimal timing of starting ADT for palliation remains contentious 8,9 and because commencement of ADT may induce or worsen cognitive decline (among other comorbidities), the problem of cognitive decline may be compounded by the introduction of this treatment earlier than may be required for oncologic reasons.…”

Section: To the Editormentioning

confidence: 99%

“…6 Harman et al 7 reported in the Baltimore longitudinal study of aging that approximately 20% of men older than 60 years, 30% older than 70 years, and 50% older than 80 years were hypogonadal. Patients who start with low testosterone levels may have a lesser change in cognition (and other parameters) than if they had a eugonadal status at baseline.7 Consequently, a number of reasons may account for the difference in the extent of findings by the two studies.Because the optimal timing of starting ADT for palliation remains contentious 8,9 and because commencement of ADT may induce or worsen cognitive decline (among other comorbidities), the problem of cognitive decline may be compounded by the introduction of this treatment earlier than may be required for oncologic reasons.10 However, a more objective approach is to predict those patients most likely to be adversely affected by ADT,6 and the findings of a single nucleotide polymorphism associated with ADT is a notable advance that heralds the way for other possible predictors of adverse consequences with ADT and other treatments. Therefore, notwithstanding the issues mentioned here, this study does advance understanding in adverse cognitive changes, which clearly are multifactorial in etiology, in our patients.…”

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confidence: 99%

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Patients Who Receive Androgen Deprivation Therapy Risk Adverse Cognitive Changes

Gardiner

Yaxley

Pakenham

et al. 2015

JCO

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TO THE EDITOR: Gonzalez et al 1 in 2015 highlighted a predilection for adverse cognitive effects by a proportion of patients who received androgen-deprivation therapy (ADT). They compared 58 patients with nonlocalized or asymptomatic metastatic prostate cancer (PCa) who were about to commence ADT and observed the participants for 12 months; the findings were compared with those from a cohort of 84 men treated with prostatectomy alone and an additional 88 men who did not have a diagnosis of PCa. They found that participants in the ADT group were more likely to demonstrate impaired cognitive performance than contemporaries in the control/ reference groups over time. Baseline age, cognitive reserve, depressive symptoms, fatigue, and hot flush interference did not moderate the impact of ADT on impaired cognitive performance. In exploratory genetic analyses, GNB3 single nucleotide polymorphism rs1047776 was associated with increased rates of impaired performance over time in the ADT group.Whether or not ADT induces adverse cognitive changes in a proportion of patients has been disputed for many years on the basis of findings from longitudinal studies, including a number that received industry funding. To resolve the question, we undertook a randomized, controlled trial of 82 men with nonlocalized PCa who were allocated to leuprorelin (Lucrin), goserelin (Zoladex), cyproterone acetate (Androcur), or no treatment and who were reassessed at 6 and 12 months after baseline; 65 participants completed 6 months, and 62 of these continued for all 12 months of follow-up.2,3 In addition to a nontreatment PCa control group, a noncancer community reference group was evaluated.Compared with baseline assessments, men who received ADT performed worse on two of 12 tests of attention and memory; 24 of 50 patients who were randomly assigned to active treatment and who were assessed 6 months later had a clinically significant decline in one or more cognitive tests, but not one patient randomly assigned to close monitoring or from the community reference group showed a decline in any test performance. At 12 months, these findings were maintained; approximately 50% of men in all treatment groups, but none of the men in the control group, had persistent significant cognitive deterioration. Although the cognitive defects were of a magnitude comparable with sleep deprivation or mild inebriation, there was no consistent association between subjective cognitive changes and objective deficits.Our study 2,3 and the study in 2015 by Gonzalez et al 1 differ in a number of ways; first, one was a randomized, controlled trial, and the other was not. Also, although both used comprehensive selections of validated instruments, the selections differed, and Gonzalez et al 1 failed to include a specific assessment for anxiety. Both trials took into account comorbidities that, along with age, can influence cognitive performance, but it is unclear if Gonzalez et al 1 made allowances for the possible influence of non-ADT medications, especially anticholine...

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Section: To the Editormentioning

confidence: 99%

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confidence: 99%

Patients Who Receive Androgen Deprivation Therapy Risk Adverse Cognitive Changes

Gardiner

Yaxley

Pakenham

et al. 2015

JCO

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“…28 Similarly, when Dr Studer reported on the results of the EORTC trial where in 939 men with prostate cancer not suitable for local curative treatment were evaluated after their randomization to immediate vs deferred ADT, he concluded that "Patients with a baseline PSA  50 ng/mL and/or a PSADT [prostate-specific antigen doubling time] 12 months were at increased risk to die from prostate cancer and might have benefited from immediate ADT, whereas patients with a baseline PSA  50 ng/mL and a slow PSADT (12 months) were likely to die of cuases unrelated to prostate cancer, and thus could be spared the burden of immediate ADT". 29 The group of men with low risk tumors who do not get treated with ADT may benefit from active surveillance where similar rates of efficacy are achieved with decreased morbidity compared to definitive therapy or androgen deprivation. 30,31 With large trials suggesting little benefit seen in screening for prostate cancer (or at least a large number needed to treat to see benefit), particularly for men over 70, the cohort who may have previously been treated with ADT due to inability to tolerate definitive therapy may now be likely to avoid screening, diagnosis and overtreatment with androgen deprivation as well.…”

Section: Androgen Therapy Not Recommendedmentioning

confidence: 99%

“…This approach includes the incorporation of known risk factors for recurrent aggressive disease to define which patients need more aggressive, early therapy and which patients may be able to be spared the adverse events of androgen deprivation at the detection of biochemical recurrence. The elements of risk-stratification may include pretreatment PSA, PSA velocity, Gleason score, volume of tumor or stage, [36][37][38] PSA velocity or total value, 29,39 PSA nadir and time to recurrence after therapy 40,41 and possibly the presence of circulating tumor cells, 42 as all of these have been shown to be associated with increased risk of progression or death from prostate cancer. …”

Section: Androgen Therapy Not Recommendedmentioning

confidence: 99%

Update on the management of prostate cancer with goserelin acetate: patient perspectives

Wilson¹

2009

CMAR

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Abstract:The guidelines for the use of androgen deprivation therapy (ADT) have changed significantly over the last 5 years. This paper reviews the current recommendations and documents the reasons for these changes, in a review of the world's literature on ADT over the last 5 years. Special emphasis on randomized controlled trials and high-impact journals was included in the Medline search and review. One hundred articles on this topic written in the last 5 years were reviewed. Fifty-nine contained nonindustry-biased findings in major-impact journals and were available in English. The benefits of ADT are evident in several areas, including neoadjuvantly and adjuvantly in patients treated with external beam radiation therapy for intermediate-and high-risk disease; in patients who have undergone prostatectomy and who are found to have lymph node involvement on surgical resection; in high-risk patients after definitive therapy; and in patients who have developed symptomatic local progression or metastasis. This paper reviews the risks and benefits in each of these scenarios and the risks of androgen deprivation in general, and delineates the areas where ADT was previously recommended, but has been found to no longer be of benefit.

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“…Although ADT improves survival for undergoing hormone therapy, biochemical recurrence after ADT remains a long-term problem to be solved. The optimal time to initiate hormone therapy for patients with a regular PSA follow-up is still under investigation [3,5,6] . As the modern pharmaceutical industry advanced, a luteinizing hormone-releasing hormone (LHRH) agonist with monthly dosing became available.…”

Section: Introductionmentioning

confidence: 99%

A comparison of androgen deprivation therapy versus surgical castration for patients with advanced prostatic carcinoma

Lin¹,

Chen²,

Hou³

et al. 2011

Acta Pharmacol Sin

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Aim: To examine the outcomes of patients with advanced prostate carcinoma who underwent medical or surgical castration. Methods: A hundred twenty one consecutive cases of patients with advanced prostate carcinoma who underwent medical or surgical castration between 2001 and 2006 were retrospectively reviewed. Associations between clinical outcomes and prognostic scoring factors were determined based on the Reijke study. In the surgical and medical castration groups, the impact on the prostate-specifi c antigen (PSA) normalization rate, the rebound rate and the disease-free survival rate were evaluated. The mean follow-up was 36.1 months. Results: In the initial 12 months, there were no statistical differences in the PSA normalization rate and the PSA rebound rate between the two groups. However, the PSA rebound rate after the 12th month (20.90% vs 40.74%, P=0.0175) and the 18th month PSA normalization rate (59.70% vs 37.04%, P=0.0217) differed signifi cantly between the two groups, and these differences were maintained to the end of the study. When comparing patients grouped according to Reijke prognosis scores, there was no difference between medical and surgical castration for the good prognosis group. However, among the patients given a poor prognosis, surgical castration was superior in terms of the PSA normalization rate, the PSA rebound rate, the tumor progression-free survival rate (P<0.001) and the overall survival rate (P<0.001). Conclusion: Advanced prostate carcinoma patients with poor pretreatment prognosis scores should undergo surgical castration rather than medical castration for better PSA rebound rates and overall survival.Keywords: androgen; surgical castration; prostate neoplasm; metastasis; prognosis; medical castration; prostate-specifi c antigen; luteinizing hormone-releasing hormone (LHRH) Acta Pharmacologica Sinica (2011) 32: 537-542; doi: 10.1038/aps.2010 published online 14 Mar 2011 Original Article # The two authors contributed equally to this work. * To whom correspondence should be addressed. In this study, we compared the clinical effectiveness of surgical and medical castration with respect to patient outcomes. We also identifi ed clinical outcomes and PSA response features that predicted favorable treatment outcomes for prostate carcinoma after ADT. Materials and methods Patient selectionAfter obtaining institutional review board approval for a retrospective study of the medical records from January 2001 to March 2006, we identified all patients who had advanced prostate carcinoma. Patients with localized prostate carcinoma received definitive therapy, such as radical surgery or radiotherapy. Patients whose clinical staging was greater than tumor stage T3, T4, or metastatic disease, received hormone therapy. In this study, we included these patients receiving hormone therapy but excluded patients on radiotherapy or chemotherapy for prostate carcinoma. However, there were some patients on palliative radiotherapy for spinal or other bone metastases.The exclusion criteria for this...

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Using PSA to Guide Timing of Androgen Deprivation in Patients with T0–4 N0–2 M0 Prostate Cancer not Suitable for Local Curative Treatment (EORTC 30891)

Cited by 136 publications

References 12 publications

Patients Who Receive Androgen Deprivation Therapy Risk Adverse Cognitive Changes

Patients Who Receive Androgen Deprivation Therapy Risk Adverse Cognitive Changes

Update on the management of prostate cancer with goserelin acetate: patient perspectives

A comparison of androgen deprivation therapy versus surgical castration for patients with advanced prostatic carcinoma

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