A phase III protocol of androgen suppression (AS) and 3DCRT/IMRT versus AS and 3DCRT/IMRT followed by chemotherapy (CT) with docetaxel and prednisone for localized, high-risk prostate cancer (RTOG 0521).

Sandler, Howard M.; Chen, Hu; Rosenthal, Seth A.; Sartor, Oliver; Gomella, Leonard G.; Amin, Mahul B.; Purdy, James A.; Michalski, Jeff M.; Garzotto, Mark; Pervez, Nadeem; Balogh, A.; Rodrigues, George; Souhami, Luís; Reaume, M. Neil; Williams, Scott; Hannan, Raquibul; Horwitz, Eric M.; Raben, Adam; Paulus, Rebecca; Shipley, William U.

doi:10.1200/jco.2015.33.15_suppl.lba5002

Cited by 34 publications

(44 citation statements)

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“…Other trials have tested the efficacy of the addition of docetaxel to ADT in patients with highrisk localized PCa [25,26]. However, the definition of the role of docetaxel in patients with high-risk localized PCa is beyond the scope of this meta-analysis.…”

Section: Discussionmentioning

confidence: 93%

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Addition of Docetaxel to Androgen Deprivation Therapy for Patients with Hormone-sensitive Metastatic Prostate Cancer: A Systematic Review and Meta-analysis

et al. 2016

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Section: Discussionmentioning

confidence: 93%

“…Evidence acquisition [25,26] were excluded. When more than one report of the same trial was available, the most recent information (corresponding to longer follow-up and higher number of events) was considered in the analysis.…”

mentioning

confidence: 99%

Addition of Docetaxel to Androgen Deprivation Therapy for Patients with Hormone-sensitive Metastatic Prostate Cancer: A Systematic Review and Meta-analysis

et al. 2016

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“…There have been FFS benefits in the GETUG-15 (22), CHAARTED (13), RTOG-0521 (23), GETUG-12 (24), and TAX-3501 (25) trials. These prior studies, however, showed contrasting results with regards to OS in men with metastatic hormone-naive disease.…”

Section: Stampede Research Armsmentioning

confidence: 99%

“…FFS was also reduced by 36% (HR 0.64, 95% CI, 0.58–0.70) (16). The same meta-analysis examined 11 trials of docetaxel for men with M0 disease and included GETUG-12 (24), RTOG-0521 (23) and STAMPEDE-M0 trials (26). These three trials captured 53% of the 3,978 men included in the M0 cohorts, and showed no survival benefit (HR 0.87, 95% CI, 0.69–1.09), although they did suggest an improved FFS (HR 0.70, 95% CI, 0.61–0.81) that was driven by data derived from the 3 largest trials (16).…”

Section: Stampede Research Armsmentioning

confidence: 99%

The STAMPEDE trial: paradigm-changing data through innovative trial design

Carthon

Antonarakis

2016

Transl. Cancer Res

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Despite the numerous regulatory approvals for prostate cancer, metastatic prostate cancer remains a huge burden for men worldwide. In an exciting development, James et al. recently published data from the Systemic Therapy in Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: a multi-stage multi-arm randomised control trial (STAMPEDE). This is an innovative multi-arm multi-stage (MAMS) trial that has utilized one control arm and several comparator arms in order to provide evidence for the inclusion of therapies beyond standard androgen deprivation alone. The patient population included: (I) men with high-risk, non-metastatic, node-negative disease; (II) men with distant-metastatic or node-positive disease; and (III) men with previouslytreated prostate cancer by prostatectomy or definitive radiotherapy presenting with relapse. Men were to continue androgen deprivation for at least 2 years. The current data published by this group supports earlier results and provides additional evidence that docetaxel utilized in an upfront fashion provides a survival benefit in men with hormone-sensitive metastatic prostate cancer. Moreover, the initial results from STAMPEDE show how therapies without a demonstrated survival benefit can be efficiently excluded from further study once the likelihood of a benefit is ruled out by a predetermined analysis. In this piece, we will review the STAMPEDE data, contrast it with existing results, and provide our perspectives on how this will affect future trial conduct in the field of prostate cancer. KeywordsAndrogen deprivation; docetaxel; stampede; zoledronic acid

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“…The smaller sample size and low proportion of extensive disease patients, could have contributed to the attenuated impact of early chemotherapy. The role of early chemotherapy in non-metastatic high risk prostate cancer receiving definitive ADT and radiation, was studied in RTOG 0521[16]. 562 evaluable patients were randomized to ADT with radiation vs ADT with radiation followed by docetaxel.…”

Section: Hormone Naïve Metastatic Prostate Cancermentioning

confidence: 99%

Multifaceted and personalized therapy of advanced prostate cancer

Thakur

Vaishampayan²

2016

Current Opinion in Oncology

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Purpose of Review A number of molecular and genomic biomarkers that possess the ability to guide treatment or “actionable targets,” are being reported in metastatic prostate cancer. In addition pathways of resistance to existing therapies and novel agents to overcome them are currently under active investigation. The next wave of investigations is focused on personalized therapy of prostate cancer. The focus of this review paper is to provide an update clinical developments in advanced prostate cancer and to highlight the ongoing investigations of biomarker discovery, and ways of overcoming therapeutic resistance. The next generation of clinical trials developing novel targets and compounds promises to be in populations enriched with specific marker expression. Recent Findings The breakthrough report, of the ability of the ARV-7 mutation, detected in circulating tumor cells, to predict lack of response to abiraterone or enzalutamide, and the remarkable responses of poly ADP ribose polymerase (PARP) inhibitors in prostate cancer with DNA repair mutations, have elevated hopes of a bright future in the biomarker driven therapeutic arena. Novel targets such as BET-1 and PI3 kinase hold promise for the possibility of overcoming resistance. Novel hormone agents are also under active study. Summary As the clinical application of the multifaceted therapies narrows down to enriched patient populations selected by genomic testing, the therapeutic efficiency will escalate considerably. Novel targets, resistance mechanisms, and relevant agents are being avidly tested and the dream of personalized medicine is emerging into reality.

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A phase III protocol of androgen suppression (AS) and 3DCRT/IMRT versus AS and 3DCRT/IMRT followed by chemotherapy (CT) with docetaxel and prednisone for localized, high-risk prostate cancer (RTOG 0521).

Cited by 34 publications

References 0 publications

Addition of Docetaxel to Androgen Deprivation Therapy for Patients with Hormone-sensitive Metastatic Prostate Cancer: A Systematic Review and Meta-analysis

Addition of Docetaxel to Androgen Deprivation Therapy for Patients with Hormone-sensitive Metastatic Prostate Cancer: A Systematic Review and Meta-analysis

The STAMPEDE trial: paradigm-changing data through innovative trial design

Multifaceted and personalized therapy of advanced prostate cancer

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