TriangleNCT03582475 · OUTCOME
Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 12 months and 24 months.
What was measured
PCWG3 is specifically designed for prostate cancer and incorporates both soft tissue and bone response assessment. RECIST 1.1 is used for evaluating responses in solid tumors, while PCWG3 combines Response evaluation criteria in solid tumors (RECIST)1.1 for soft tissue assessment with specific criteria for bone scans. The PCWG3 response criteria was used to report the portion of participants with rPFS at their 12 and 24 month assessments.
Analysis population: The Primary outcome of Radiographic PFS (rPFS) with response criteria based off Prostate Cancer Working Group 3 (PCWG3) only applies to Prostate cancer patients enrolled into cohort 2. This criteria does not apply to Bladder cancer patients that enrolled in Cohort 1.
Groups in this outcome
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer | 0 |
| Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 7 |
Reported measurements
12 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | .43 | Not reported | 0.18 | 1.00 | Not reported |
24 Months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 2: Small Cell or Neuroendocrine Prostate Cancer | 0.14 | Not reported | 0.02 | 0.88 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 0.18
- upper Limit
- 1.00
- value
- .43
- title
- 12 Months
- categories
- measurements
- group Id
- OG001
- lower Limit
- 0.02
- upper Limit
- 0.88
- value
- 0.14
- title
- 24 Months
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- PCWG3 is specifically designed for prostate cancer and incorporates both soft tissue and bone response assessment. RECIST 1.1 is used for evaluating responses in solid tumors, while PCWG3 combines Response evaluation criteria in solid tumors (RECIST)1.1 for soft tissue assessment with specific criteria for bone scans. The PCWG3 response criteria was used to report the portion of participants with rPFS at their 12 and 24 month assessments.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV
- id
- OG000
- title
- Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
- description
- Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
- param Type
- NUMBER
- population Description
- The Primary outcome of Radiographic PFS (rPFS) with response criteria based off Prostate Cancer Working Group 3 (PCWG3) only applies to Prostate cancer patients enrolled into cohort 2. This criteria does not apply to Bladder cancer patients that enrolled in Cohort 1.
- reporting Status
- POSTED
- time Frame
- 12 months and 24 months.
- title
- Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2)
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice