Trial · NCT01260688
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2) | 3 months | Progression is defined using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, which includes a compilation of prostate-specific antigen (PSA), bone scan, and CT-scan assessments (Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Number of Participants With Toxicities | Up to 30 days after last dose of study drugs | Incidence of toxicities graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0 |
| Secondary | Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale | After every cycle (median duration on study = 4 cycles) | Present Pain Intensity (PPI) scale. Scale is measured 0-5, where 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain and 5=excruciating pain Participants who were up to completing the assessment (did not decline) and who reported a score \>=2 at the end of any cycle are reported. |
| Secondary | Number Who Experienced Study Medication Dose Intensity | Cycle 1 (an average of 28 days) | Number of patients who experienced study medication dose of over 80% during Cycle 1 was assessed. |
| Secondary | Treatment Discontinuation | Cycle 1 (average of 28 days) | Discontinuation of treatment in cycle 1 (average of 28 days) |
| Secondary | Treatment Discontinuation Due to Adverse Events (AEs) | Through study completion (median duration on study = 4 cycles) | Treatment discontinuation due to Adverse Events |
| Secondary | Non-AE Related Treatment Discontinuation | Through study completion (median duration on study = 4 cycles) | Non-Adverse Event related Treatment Discontinuation |
| Secondary | Overall Response Rate | Duration of Study (median duration on study = 4 cycles) | Best overall response rate of each evaluable patient |
| Secondary | Treatment Related Deaths | Through study completion (median duration on study = 4 cycles) | Number of treatment related deaths |
| Secondary | Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced | Through study completion (median duration on study = 4 cycles) | Participants for which beta-C telopeptide was reduced |
| Secondary | Number of Participants With Increased Alkaline Phosphatase BAP | Through study completion (median duration on study = 4 cycles) | Number of participants with increased alkaline phosphatase BAP |
| Secondary | Dose Interruption Due to AEs | Through study completion (median duration on study = 4 cycles) | The number of participants with dose-interruptions in each arm due to adverse events |
| Secondary | Dose Reductions | Duration of Study (median duration on study = 4 cycles) | The number of participants with dose reductions in each arm |
| Secondary | Overall Response Rate | Duration of Study (median duration on study = 4 cycles) | Response Rate of Stable Disease and Progressive Disease |
| Secondary | Quality of Life Assessment Using Functional Assessment of Cancer Therapy - Prostate (FACT-P) Questionnaire | Up to 16 weeks | Scale is measured on a range from 0 (worst quality of life) to 156 (best quality of life). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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