Trial · NCT00385580
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 40
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =\>30% in sum of longest diameter \[LD\] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease \[PD: =\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors \[RECIST\]. |
| Primary | Percentage of Participants With a Response | Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks. | Response = confirmed PSA response (decrease in PSA =\>50% from baseline), confirmed improved bone scan (disappearance of =\> 1 lesion, no new lesions, new pain not developing), confirmed CR (disappearance of all lesions) or confirmed PR (=\>30% in sum of LD of all lesions compared to baseline sum LD), SD (neither sufficient increase for PD \[=\>20% increase in sum of LD of all target lesions\] nor sufficient shrinkage for PR), based on RECIST. |
| Secondary | Number of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline, for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements. |
| Secondary | Percentage of Participants With a Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer and a PSA response is defined as a decrease in the PSA value by at least 50% from baseline for 2 successive evaluations, each at least 2 weeks apart, for a total of 3 measurements. |
| Secondary | Number of Months of Decrease in PSA by at Least 50% From Baseline | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. The duration of PSA response is measured from the time that the first of the 2 consecutive measurements met the criteria for confirmed PSA response, until the date of the first of the 3 consecutive measurements that confirm PSA progression, or the date of disease progression, or the date of death. |
| Secondary | Number of Participants With Decrease in PSA Velocity | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. PSA velocity measures the rate of change of PSA values. A decrease in PSA values and hence PSA velocity is an early indicator of potential anti-tumor activity. |
| Secondary | Number of Participants With Decrease in PSA Log Slope | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. A decrease in PSA value is an early indicator of potential anti-tumor activity. Log (PSA) is assumed to have a linear relationship with time. The PSA log slope is defined as the slope of the log PSA line. |
| Secondary | Number of Participants With Increase in PSA Doubling Time | Prior to treatment with the study drug, Week 4, Week 8, Week 12 and every 4 weeks thereafter. | PSA is a marker of prostate cancer. PSA doubling time is defined as log 2 divided by the slope of the log PSA line. An increase in PSA doubling time indicates improvement in anti-tumor activity. |
| Secondary | Number of Participants With CR or PR | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | Tumor response was defined as the number of participants whose best response was CR or PR, per RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD |
| Secondary | Number of Participants With CR, PR or SD | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | Disease control rate is defined as the number of participants whose best response was CR, PR or SD, per RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD; SD: neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR; PD: defined as appearance of new lesion/s, or \>=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. |
| Secondary | Number of Participants With a Confirmed Improved Bone Scan | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart. |
| Secondary | Percentage of Participants With Confirmed Improved Bone Scan | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | An improved bone scan was defined as 1 or more of the following: disappearance of at least 1 lesion, no new lesions appearing since the most recent prior assessment, or new pain not developing in an area that was previously visualized. A response is considered confirmed if it is noted on 2 examinations at least 4 weeks apart. |
| Secondary | Number of Participants With Disease Progression | Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment. | Disease progression: progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI), not as evaluated by bone scan (non-measurable lesions included visceral and bone lesions), loss of PSA response (only for participants who achieved a PSA response) or Investigator-defined clinical progression based on physical examination, history, symptoms, and ECOG-PS. For participants who did not progress or die, date of last PSA measurement or tumor assessment was used, whichever occurred first. |
| Secondary | Median Number of Months to Disease Progression | Prior to treatment with the study drug, Week 12 and every 12 weeks thereafter and at the end of the treatment. | Measured from date of first dose to date of first 3 consecutive measurements that confirm PSA progression, date of disease progression,or death date.Disease progression:progression of target lesions or unequivocal progression of non-measurable lesions/disease as evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI),loss of PSA response or Investigator-defined clinical progression based on physical examination,history,symptoms,and ECOG-PS.For participants who did not progress or die,date of last PSA measurement or tumor assessment was used, whichever occurred first. |
| Secondary | Median Change From Baseline in Individual FAPSI Scores at Week 12 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities. |
| Secondary | Median Change From Baseline in Total FAPSI-8 Scores at Weeks 12, 24 and 36 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | The FAPSI-8 is a symptom index comprised of the most important clinician-rated symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. It includes 8 items developed to measure symptoms/concerns specific to prostate cancer such as fatigue, pain (3-items), weight loss, difficulty with urination (2-items) and concerns about the condition becoming worse. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). |
| Secondary | Median Change From Baseline in Individual FAPSI Scores at Week 24 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | FAPSI-8:symptom index of important clinician-rated symptoms/concerns to monitor when assessing value of treatment for advanced prostate cancer. Participants respond to each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). GP1:I have lack of energy, GP4:I have pain, GE6:I worry that my condition will get worse, C2: I am losing weight, P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do, P7:I have difficulty urinating, P8:My problems with urinating limit my activities. |
| Secondary | Median Change From Baseline in Individual FAPSI Scores at Week 36 | Prior to treatment with the study drug, Week 12, every 12 weeks thereafter and at the end of the treatment. | FAPSI-8:index of symptoms/concerns when assessing value of treatment for advanced prostate cancer.Participants respond to each item on 5-point Likert-type scale:0 (not at all) to 4 (very much).GP1:I have lack of energy,GP4:I have pain,GE6:I worry that my condition will get worse,C2:I am losing weight,P2:I have certain areas in my body where I experience significant pain,P3:My pain keeps me from doing things I want to do,P7:I have difficulty urinating,P8:My problems with urinating limit my activities. The number of participants for whom these data are available is too small for analysis. |
| Secondary | Number of Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs | From start of study drug therapy up to 30 days after the last dose. | AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. |
| Secondary | Number of Participants Who Experienced Drug-related SAEs, Drug-related AEs, Drug-related Grade 3/4 AEs and Discontinuations Due to Drug-related AEs. | From start of study drug therapy up to 30 days after the last dose. | Drug-related AEs are those events with a relationship to the study therapy of certain; probable; possible; or missing. Drug-related SAEs are those events with any relationship to the study therapy. Drug-related AEs were graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0: Grade 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. Participants who discontinued the study due to any drug-related AEs were also recorded. |
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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