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Trial · NCT00450619

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Patients With Stable Disease at 4 Months.4.7 monthsparticipantsNUMBER
PRIMARYProgression Free Survival (PFS)4 monthsmonthsMEDIAN
SECONDARYToxicity5 years, 5 monthsParticipantsNUMBER
SECONDARYNumber of Participants With Prostate-Specific Antigen (PSA) ≥ 30%4 monthsparticipantsNUMBER
SECONDARYNumber of Participants With Prostate-Specific Antigen (PSA) ≥50%4 monthsparticipantsNUMBER
SECONDARYOverall SurvivalFrom date of randomization until death or last follow up, whichever comes first, assessed up to 14 months.MonthsMEDIAN
SECONDARYArm A: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatmentApproximately 60 days
(a)Cytokine or CD107a in CD4 or CD8. \*Pts displayed pre-existing PSA-specific T-cell responses. Numbers 274, 630, and 1427 are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.
Absolute # CD4 or CD8 producing cytokineNUMBER
SECONDARYArm B: Prostate-Specific Antigen (PSA) T-cell Responses Post-vs. Pre-treatmentApproximately 60 days
(a)Cytokine or CD107a in CD4 or CD8. \*Pts displayed pre-existing PSA-specific T-cell responses. Numbers 786, 374, 345, 402, 821, 815, 5269, 453, 633, 1242 \& 0 for PT 2 CD4/CD8 IL2 \& 0 for PT 16 TNF are those positive post- vs. pre-vaccination. Absolute # CD4 or CD8 producing cytokine/CD107a+/1x10(6) cells plated at start of in vitro stimulation.
Absolute # CD4 or CD8 producing cytokineNUMBER
SECONDARYObjective Response (Complete Response + Partial Response)4 weeksNot all participants was measureable by RECIST.participantsNUMBER
SECONDARYPalliation: Pain at BaselineBaselineparticipantsNUMBER
SECONDARYPalliation: Improvement in Baseline Painpost quadramet (samarium)participantsNUMBER

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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