NCT03511664 · OUTCOME
Concomitant Drug Use for Health Economics Analysis
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Source last updated 2025-01-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
What was measured
The list of concomitant drugs as captured on the concomitant medication/therapy CRF page to include in each category was pre-specified and flagged prior to the pre planned analyses. (1) Bisphosphonates (including but not limited to zoledronic acid, alendronic acid, etc.), denosumab, and other bone targeted therapies), (2) Corticosteroids for systemic use (3), Antifungals for systemic use (i.e. ketoconazole), (4) ESA (erythropoietin stimulating agents, i.e. epoetin alfa), (5) Granulocyte macrophage colony-stimulating factor (GM-CSF), (6) Novel androgen axis drugs (NAADs; i.e. enzalutamide, abiraterone, apalutamide), (7) Antiemetics and (8) Opioid analgesics use for cancer-related pain.
Analysis population: PFS Full Analysis Set (PFS-FAS)
Groups in this outcome
Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 385 |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 196 |
|---|
Reported measurements
Bisphosphonates
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 169 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 88 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 216 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 108 | Not reported | Not reported | Not reported | Not reported |
|---|
Corticosteroids
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 246 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 113 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 139 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 83 | Not reported | Not reported | Not reported | Not reported |
|---|
Antifungals
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 384 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 192 | Not reported | Not reported | Not reported | Not reported |
|---|
Erythropoietin Stimulating Agents
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 377 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 194 | Not reported | Not reported | Not reported | Not reported |
|---|
Granulocyte macrophage colony-stimulating factor
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 378 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 193 | Not reported | Not reported | Not reported | Not reported |
|---|
Novel Androgen Axis Drugs
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 188 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 115 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 197 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 81 | Not reported | Not reported | Not reported | Not reported |
|---|
Antiemetics
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 232 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 153 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 151 | Not reported | Not reported | Not reported | Not reported |
|---|
Opioid analgesics
Yes
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 199 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 96 | Not reported | Not reported | Not reported | Not reported |
|---|
No
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC) | 186 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone | 100 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 169
- group Id
- OG001
- value
- 88
- title
- Yes
- measurements
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 108
- title
- No
- title
- Bisphosphonates
- categories
- measurements
- group Id
- OG000
- value
- 246
- group Id
- OG001
- value
- 113
- title
- Yes
- measurements
- group Id
- OG000
- value
- 139
- group Id
- OG001
- value
- 83
- title
- No
- title
- Corticosteroids
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- title
- Yes
- measurements
- group Id
- OG000
- value
- 384
- group Id
- OG001
- value
- 192
- title
- No
- title
- Antifungals
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 2
- title
- Yes
- measurements
- group Id
- OG000
- value
- 377
- group Id
- OG001
- value
- 194
- title
- No
- title
- Erythropoietin Stimulating Agents
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- title
- Yes
- measurements
- group Id
- OG000
- value
- 378
- group Id
- OG001
- value
- 193
- title
- No
- title
- Granulocyte macrophage colony-stimulating factor
- categories
- measurements
- group Id
- OG000
- value
- 188
- group Id
- OG001
- value
- 115
- title
- Yes
- measurements
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 81
- title
- No
- title
- Novel Androgen Axis Drugs
- categories
- measurements
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 45
- title
- Yes
- measurements
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 151
- title
- No
- title
- Antiemetics
- categories
- measurements
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 96
- title
- Yes
- measurements
- group Id
- OG000
- value
- 186
- group Id
- OG001
- value
- 100
- title
- No
- title
- Opioid analgesics
- denoms
- counts
- group Id
- OG000
- value
- 385
- group Id
- OG001
- value
- 196
- units
- Participants
- description
- The list of concomitant drugs as captured on the concomitant medication/therapy CRF page to include in each category was pre-specified and flagged prior to the pre planned analyses. (1) Bisphosphonates (including but not limited to zoledronic acid, alendronic acid, etc.), denosumab, and other bone targeted therapies), (2) Corticosteroids for systemic use (3), Antifungals for systemic use (i.e. ketoconazole), (4) ESA (erythropoietin stimulating agents, i.e. epoetin alfa), (5) Granulocyte macrophage colony-stimulating factor (GM-CSF), (6) Novel androgen axis drugs (NAADs; i.e. enzalutamide, abiraterone, apalutamide), (7) Antiemetics and (8) Opioid analgesics use for cancer-related pain.
- groups
- description
- Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
- id
- OG000
- title
- Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
- description
- Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
- id
- OG001
- title
- Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- PFS Full Analysis Set (PFS-FAS)
- reporting Status
- POSTED
- time Frame
- From date of randomization till 30 days safety fup, assessed up to approximately 32 months (Primary Analysis cut-off date = 27-Jan-2021)
- title
- Concomitant Drug Use for Health Economics Analysis
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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