Eligibility and Outcomes Reporting Guidelines for Clinical Trials for Patients in the State of a Rising Prostate-Specific Antigen: Recommendations From the Prostate-Specific Antigen Working Group

Abstract

Methodology to show that an intervention alters the natural history of prostate cancer is described. At each stage of development, only agents with sufficient activity should be moved forward.

Is there a role for positron emission tomography imaging in the early evaluation of prostate cancer relapse?

“…2 For instance, 18 F-FDG may be superior and more cost effective for the detection of distant disease, whereas 11 C-acetate or 11 C-choline may prove more accurate in identifying local recurrence and/or nodal metastasis. Thus, rather than simply replacing a tracer with another, a multitracer approach may be needed to fully exploit the potential of PET imaging in the setting of biochemical failure.…”

“…1 These patients have, by definition, a rising marker with no evidence of disease on standard imaging studies. 2 The median amount of time that a patient will spend in this state before developing overt metastatic disease is 8 years, with death occurring at a median of 5 years after clinical progression. 3 However, biochemical recurrence represents a wide spectrum of clinical risk.…”

Biomarkers for the Development of Cancer Vaccines

“…In clinical practice, PSA rises are generally accepted to be a sign of disease progression and may trigger new or additional treatment interventions, including use of investigational products [46]. Thus, PSA increases have commonly been used in early phase clinical trials as a surrogate for disease progression, while reductions in absolute PSA levels have been used in such studies as a surrogate for clinical efficacy [2].…”

“…However, these too have yet to achieve acceptance with regulatory authorities as definitive biomarkers [46]. late stage data with very recent failures in a large Phase III melanoma trial [101].…”

Society of Urologic Oncology position statement: Redefining the management of hormone‐refractory prostate carcinoma

“…Two new and relevant subsets of patients with prostate carcinoma were defined by the integration of PSA assessment into clinical practice. The first subset of patients included those with evidence of biochemical disease recurrence (i.e., PSA disease recurrence) 4,5 after curative intent therapy (radical prostatectomy/radiotherapy in hormone-naive patients). The second subset of patients comprised those with or without clinical metastases, who, after being managed by androgen deprivation, have an increasing level of PSA in the absence of obvious clinical disease progression.…”