A phase III randomized trial of intermittent versus continuous androgen suppression for PSA progression after radical therapy (NCIC CTG PR.7/SWOG JPR.7/CTSU JPR.7/ UK Intercontinental Trial CRUKE/01/013).

Crook, Juanita; O’Callaghan, Chris; Ding, Kevin; Duncan, Graeme; Dearnaley, D.P.; Higano, Celestia S.; Horwitz, E.; Frymire, Eliot; Malone, Shawn; Chin, J.; Nabid, Abdenour; Warde, P.; Corbett, Tom; Angyalfi, Steve; Goldenberg, S. Larry; Gospodarowicz, M.K.; Saad, Fred; Logue, John P; Schellhammer, Paul F.; Klotz, Laurence

doi:10.1200/jco.2011.29.15_suppl.4514

Cited by 28 publications

(11 citation statements)

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“…24 While certain trials are inarguably more expensive than SOC, future benefits may offset these short-term costs. 25 Even though the results of the present study are limited to a singletumour group, it represents a first step towards dispelling a commonly held belief that clinical trials are a burden on a public-payer health-care system and a larger, multi-tumour group analysis is currently underway. The authors would like to encourage the research community to engage in similar analyses to allow for comparisons between different institutional practices across the country.…”

Section: Resultsmentioning

confidence: 93%

Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

Jones¹,

Syme²,

Eliasziw³

et al. 2012

CUAJ

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Introduction: Clinical trials are a critical component of improving cancer prevention and treatment strategies. However, the perception that patients enrolled in trials consume more resources than those receiving the standard-of-care (SOC) has contributed to an increasingly research-averse environment. Current economic data pertaining to the per-patient costs of prostate cancer trials relative to SOC treatment are limited. Methods: A retrospective observational cohort study was conducted to compare costs incurred by 59 prostate cancer patients participating in a mix of industry and non-industry sponsored clinical trials with costs incurred by an equal number of eligible nonparticipants who received SOC over a year. Resource utilization was tracked and quantified to standardized price templates. Results: No difference in overall resource utilization was seen between trial and SOC patients (two-tailed t-test, n = 118, p = 0.99). Variability in the types of resources used by each group indicated that, while trial patients may take up significantly more clinic time (p = 0.001) and undergo more tests and procedures (p = 0.001), SOC patients are more likely to receive other costly interventions, such as radiation therapy (p < 0.001). Other variables (e.g., pathology, diagnostic imaging, prescribed therapies) were statistically indistinguishable between groups. Conclusion: This study revealed differences in the cost distribution of patients enrolled in clinical trials versus those receiving SOC, which could be used to improve resource allocation. The lack of evidence for a difference in overall cost provides an argument for payers to more fully support clinical research without fear of adverse financial consequences. Further analysis is required.

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Section: Resultsmentioning

confidence: 93%

Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

Jones¹,

Syme²,

Eliasziw³

et al. 2012

CUAJ

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“…Further potential benefits of IHT include reduced sideeffects compared with continuous therapy, improved QoL (especially recovery of sexual potency), health care cost savings, and delayed emergence of hormonal refractoriness [6][7][8]. However, no randomised studies to date have assessed IHT delivered as monotherapy with antiandrogens (cyproterone acetate; CPA).…”

Section: Introductionmentioning

confidence: 99%

Locally Advanced and Metastatic Prostate Cancer Treated with Intermittent Androgen Monotherapy or Maximal Androgen Blockade: Results from a Randomised Phase 3 Study by the South European Uroncological Group

Silva

Gonçalves

et al. 2014

European Urology

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a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m j o u r n a l h o m e p a g e : w w w . e u r o p e a n u r o l o g y . c o m Article info AbstractBackground: Few randomised studies have compared antiandrogen intermittent hormonal therapy (IHT) with continuous maximal androgen blockade (MAB) therapy for advanced prostate cancer (PCa). Objective: To determine whether overall survival (OS) on IHT (cyproterone acetate; CPA) is noninferior to OS on continuous MAB. Design, setting, and participants: This phase 3 randomised trial compared IHT and continuous MAB in patients with locally advanced or metastatic PCa. Intervention: During induction, patients received CPA 200 mg/d for 2 wk and then monthly depot injections of a luteinising hormone-releasing hormone (LHRH; triptoreline 11.25 mg) analogue plus CPA 200 mg/d. Patients whose prostate-specific antigen (PSA) was <4 ng/ml after 3 mo of induction treatment were randomised to the IHT arm (stopped treatment and restarted on CPA 300 mg/d monotherapy if PSA rose to 20 ng/ml or they were symptomatic) or the continuous arm (CPA 200 mg/d plus monthly LHRH analogue). Outcome measurements and statistical analysis: Primary outcome measurement was OS. Secondary outcomes included cause-specific survival, time to subjective or objective progression, and quality of life. Time off therapy in the intermittent arm was recorded. Results and limitations: We recruited 1045 patients, of which 918 responded to induction therapy and were randomised (462 to IHT and 456 to continuous MAB). OS was similar between groups ( p = 0.25), and noninferiority of IHT was demonstrated (hazard ratio [HR]: 0.90; 95% confidence interval [CI], 0.76-1.07). There was a trend for an interaction between PSA and treatment ( p = 0.05), favouring IHT over continuous therapy in patients with PSA 1 ng/ml (HR: 0.79; 95% CI, 0.61-1.02). Men treated with IHT reported better sexual function. Among the 462 patients on IHT, 50% and 28% of patients were off therapy for 2.5 yr or >5 yr, respectively, after randomisation. The main limitation is that the length of time for the trial to mature means that other therapies are now available. A second limitation is that T3 patients may now profit from watchful waiting instead of androgen-deprivation therapy. Conclusions: Noninferiority of IHT in terms of survival and its association with better sexual activity than continuous therapy suggest that IHT should be considered for use in routine clinical practice.

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“…23 In contrast, three trials, Bladder.11, PR.11 and PR.12 were closed due to accrual failure. Because of this, and a need to clarify other methodologic issues, the currently-approved PR.15 trial comparing external beam radiation therapy with or without high-dose rate brachytherapy in men with intermediate-risk prostate cancer is planned to move forward first as a feasibility trial and will include success of accrual as one of its endpoints.…”

Section: Ncic Clinical Trials Groupmentioning

confidence: 99%

Cooperative Group Cancer Clinical Trials: An NCIC Clinical Trials Group Perspective

Meyer¹,

Stanton²,

Parulekar³

et al. 2013

CUAJ

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A phase III randomized trial of intermittent versus continuous androgen suppression for PSA progression after radical therapy (NCIC CTG PR.7/SWOG JPR.7/CTSU JPR.7/ UK Intercontinental Trial CRUKE/01/013).

Cited by 28 publications

References 0 publications

Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

Incremental costs of prostate cancer trials: Are clinical trials really a burden on a public payer system?

Locally Advanced and Metastatic Prostate Cancer Treated with Intermittent Androgen Monotherapy or Maximal Androgen Blockade: Results from a Randomised Phase 3 Study by the South European Uroncological Group

Cooperative Group Cancer Clinical Trials: An NCIC Clinical Trials Group Perspective

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