scholarly journals Saracatinib as a metastasis inhibitor in metastatic castration-resistant prostate cancer: A University of Chicago Phase 2 Consortium and DOD/PCF Prostate Cancer Clinical Trials Consortium Study

The Prostate ◽  
2015 ◽  
Vol 76 (3) ◽  
pp. 286-293 ◽  
Author(s):  
Edwin M. Posadas ◽  
Rafi S. Ahmed ◽  
Theodore Karrison ◽  
Russell Z. Szmulewitz ◽  
Peter H. O'Donnell ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
Phase 2 ◽  
University Of Chicago ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Metastasis Inhibitor

The Prostate Cancer Clinical Trials Working Group (PCCTWG) consensus criteria for phase II clinical trials for castration-resistant prostate cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5057-5057 ◽  
Author(s):  
H. I. Scher ◽  
S. Halabi ◽  
I. Tannock ◽  
M. Morris ◽  
C. Higano ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Bone Scan ◽  
Clinical Manifestations ◽  
Disease Assessment ◽  
Phase 2 ◽  
Castration Resistant Prostate Cancer ◽  
Time To Event ◽  
Phase 3 ◽  
Castration Resistant

5057 Background: The clinical manifestations of castration-resistant metastatic prostate cancer pose challenges to the design of phase 2 trials. In 1999, PSAWG issued a consensus report to standardize phase 2 design and endpoint definitions. A reassessment is reported. Methods: At 4 meetings, and using electronic communication, PCCTWG is seeking consensus on the design and analysis of phase 2 trials that can inform decisions about proceeding to phase 3. Results: PCCTWG recognizes that trial objectives, and details of design and analysis depend on the agent under study. PCCTWG recommends: (i) A standard disease assessment that includes prior treatment history, bone scan, and CT of the chest, abdomen and pelvis; (ii) Revision of eligibility criteria to lower PSA thresholds and serum testosterone levels; (iii) Emphasis on time-to-event endpoints including clinical, biochemical (e.g. PSA) or radiologic progression, recognizing that molecular targeted agents may delay progression without influencing initial response. (iv) Independent reporting of biochemical, radiographic, and clinical outcomes, avoiding grouped categorizations of complete or partial response, or stable disease. (v) Treating for a minimum of 12 weeks before assessing disease status, as the onset of PSA declines are often delayed, verifying that an agent does not influence release of PSA from cells. (vi) RECIST criteria are appropriate for changes in measurable disease, separating nodal and visceral sites. (vii) Changes in bone scan should be reported as “new lesions” or “no new lesions”, confirming findings of progression on a second scan. (viii) Pain and analgesic intake should be assessed using validated scales. (ix) Due to inherent variability, randomization to experimental and control groups is preferred, and innovative designs, e.g. expanding selected arms of randomized phase 2 trials to phase 3. Conclusions: PCCTWG recommends increasing emphasis on time to event endpoints as decision aids in proceeding from phase 2 to phase 3 trials. The recommendations will evolve as data are generated from phase 3 studies on the ability of intermediate endpoints to predict for clinical benefit. Support: MSKCC SPORE (CA 92629), Prostate Cancer Foundation. No significant financial relationships to disclose.

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