Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
| Group | Value (percentage of participants) |
|---|---|
| Abiraterone+Radiotherapy+ADT | 54.54 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
NCT0171705317 Jan 2014 to 31 Aug 2021
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.
Experimental
Abiraterone acetate
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Outcomes the sponsor listed as primary.
Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
Time frame · 1 year
The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of \<0.1 ng/mL.
Time to PSA Nadir
Time frame · 1 year
The median time in months to the lowest PSA value from the start of study therapy.
PSA Nadir Value
Time frame · 1 year, 2 years
The lowest PSA value from the start of study therapy.
Percentage of Participants With Biochemical Progression-free Survival (BPFS)
Time frame · 36 and 48 months
Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
Metastasis or Systemic Therapy
Time frame · up to 5 years (60 months)
Time to either imaging indicating metastasis or beginning a new systemic therapy. This is a distinctly different measure from number 4 above. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case.
Testosterone Recovery
Time frame · up to 5 years
Time to testosterone recovery
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
Time frame · 1 year, 2 years, 3 years, 4 years, 5 years
Percentage of men with 1, 2, 3, 4 and 5 year PSA \< 1.5ng/ml in setting of non-castrate testosterone.
Safety and Tolerability
Time frame · 6 months
The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| Abiraterone+Radiotherapy+ADT | 54.54 |
| Group | Value (months) |
|---|---|
| Abiraterone+Radiotherapy+ADT | 8.9 |
| Group | Value (ng/mL) |
|---|---|
| Abiraterone+Radiotherapy+ADT | 0.03 |
| Group | Value (percentage of participants) |
|---|---|
| Abiraterone Acetate | 96.96 |
| Group | Value (months) |
|---|---|
| Abiraterone Acetate | 60 |
| Group | Value (months) |
|---|---|
| Abiraterone Acetate | 9.2 |
| Group | Value (percentage of patients) |
|---|---|
| Abiraterone+Radiotherapy+ADT | 100 |
| Group | Value (Participants) |
|---|---|
| Abiraterone+Radiotherapy+ADT | 12 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Abiraterone+Radiotherapy+ADTAbiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate. | 0 / 37 | 4 / 37 | 36 / 37 |
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Studies that cite this trial.
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