An observational study in Prostate Cancer, sponsored by AbbVie (prior sponsor, Abbott). Completed. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)
Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days, subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6 months (6-9 months) during which PSA and testosterone levels were measured every 3 months. When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (IAD). Participants with PSA decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (CAD) or chemotherapy.
Therapy was stopped if participants had PSA decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent treatment was performed according to a similar scheme. PSA and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate Cancer (HRPC) developed.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 300 is above the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
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Participants with advanced PCa
Histologically confirmed advanced PCa meeting the following criteria:
Exclusion Criteria:
Contraindications to administration of leuprorelin:
Participants with advanced PCa
Mean Duration of Leuprorelin Exposure
Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.
Time frame: 24 months
Mean Duration of Each Leuprorelin Cycle
Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.
Time frame: 24 months
Median Number of Leuprorelin Cycles
The Participants were on IAD regimen and the data are reported as number of cycles with full range.
Time frame: 24 months
Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen
The data are reported as percentage of participants.
Time frame: 24 months
Number of Participants Who Switched to IAD Regimen by Visit
The data are reported as number of participants.
Time frame: 24 months
Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC)
Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Time to Progression of HRPC
Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Time to Progression of HRPC in Participants Not Started on IAD Regimen
Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Survival Time
Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Mean Duration of Treatment-off Time in IAD Regimen
Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin \[cycle N+1\] minus last dose date \[cycle N\] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Median Percentage of Time Off-treatment During 2 Years IAD Regimen
The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.
Time frame: Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit
Duration of IAD Regimen Induction Phase
Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.
Time frame: At least 6-9 months after Baseline (enrollment)
Number of Participants Who Received IAD Regimen During the Study
The data are reported as number of participants.
Time frame: 24 months
Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study
The data are reported as number of participants.
Time frame: 24 months
| Milestone | Advanced Prostate Cancer (PCa) |
|---|---|
| Started | 300 |
| Completed | 194 |
| Not completed | 106 |
| Withdrew: Adverse event | 3 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Administrative reason | 6 |
| Withdrew: Progression/hormone-refractory pca | 55 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Other | 1 |
| Withdrew: No decrease of prostate specific antigen | 7 |
| Withdrew: Investigator unable to be contacted | 17 |
Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation.
| Months | Advanced PCa |
|---|---|
| All participants (N=240) | 7.70 ± 1.25 |
| Participants with no progression (N=207) | 7.75 ± 1.13 |
| Participants with progression (N=33) | 7.32 ± 1.79 |
Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation.
| Months | Advanced PCa |
|---|---|
| All participants | 19.74 ± 6.39 |
| Participants with no progression (N=227) | 21.25 ± 5.31 |
| Participants with progression (N=56) | 13.62 ± 6.79 |
Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation.
| Months | Advanced PCa |
|---|---|
| All Participants: Cycle 1 (N=282) | 7.63 ± 1.73 |
| All Participants: Cycle 2 (N=238) | 5.60 ± 2.21 |
| All Participants: Cycle 3 (N=61) | 4.64 ± 1.63 |
| All Participants: Cycle 4 (N=7) | 3.44 ± 1.09 |
| All Participants: Cycle 5 (N=1) | 3.30 ± NA |
| Participants with No Progression: Cycle 1 (N=226) | 7.68 ± 1.49 |
| Participants with No Progression: Cycle 2 (206) | 5.70 ± 2.08 |
| Participants with No Progression: Cycle 3 (N=52) | 4.72 ± 1.55 |
| Participants with No Progression: Cycle 4 (N=7) | 3.44 ± 1.09 |
| Participants with No Progression: Cycle 5 (N=1) | 3.30 ± NA |
| Participants with Progression: Cycle 1 (N=56) | 7.43 ± 2.49 |
| Participants with Progression: Cycle 2 (N=32) | 4.96 ± 2.84 |
| Participants with Progression: Cycle 3 (N=9) | 4.19 ± 2.08 |
Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC.
| Participants | Advanced PCa |
|---|---|
| All Participants | 36 |
| Participants who started IAD | 28 |
| Participants who did not start IAD | 8 |
The Participants were on IAD regimen and the data are reported as number of cycles with full range.
| Cycles | Advanced PCa |
|---|---|
| Median Number of Leuprorelin Cycles | 2 (1 to 5) |
Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range).
| Months | Advanced PCa |
|---|---|
| All Participants (N=36) | 17.12 (3.00 to 24.80) |
| Participants who started IAD (N=28) | 19.10 (5.00 to 24.80) |
| Participants who did not start IAD (N=8) | 8.11 (3.00 to 15.40) |
Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed.
| Months | Advanced PCa |
|---|---|
| Median Time to Progression of HRPC in Participants Not Started on IAD Regimen | 12.8 (12.8 to 15.4) |
Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range.
| Months | Advanced PCa |
|---|---|
| All Participants (N=4) | 18.94 (11.80 to 24.80) |
| Participants who started IAD (N=2) | 24.44 (24.10 to 24.80) |
| Participants who did not start IAD (N=2) | 12.76 (11.80 to 13.80) |
The data are reported as number of participants.
| Participants | Advanced PCa |
|---|---|
| All participants | 243 |
| Participants with no progression | 210 |
| Participants with progression | 33 |
The data are reported as number of participants.
| Participants | Advanced PCa |
|---|---|
| All participants | 69 |
| Participants with no progression (N=210) | 68 |
| Participants with progression (N=33) | 1 |
The data are reported as percentage of participants.
| Percentage of participants | Advanced PCa |
|---|---|
| Overall Study | 31.4 |
| Cycle 1 | 15.2 |
| Cycle 2 (N=240) | 14.6 |
| Cycle 3 (N=119) | 62.2 |
| Cycle 4 (N=17) | 64.7 |
| Cycle 5 (N=1) | 0.0 |
Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin \[cycle N+1\] minus last dose date \[cycle N\] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation.
| Months | Advanced PCa |
|---|---|
| Mean Duration of Treatment-off Time in IAD Regimen | 7.12 ± 2.61 |
The data are reported as number of participants.
| Participants | Advanced PCa |
|---|---|
| Visit 2 After One Year (N=257) | 237 |
| Visit 3 After Two Years (N=225) | 197 |
The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range.
| Percentage of time off-treatment | Advanced PCa |
|---|---|
| Median Percentage of Time Off-treatment During 2 Years IAD Regimen | 33.45 (0.00 to 67.60) |
Collected over From signing of informed consent up to 24 months of observation of treatment period and 30 days of follow up period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Advanced PCa | — | 13/283 (4.6%) | 73/283 (25.8%) |
| Event | Advanced PCa |
|---|---|
| DISEASE PROGRESSIONGeneral disorders | 7/283 |
| CARDIAC DISORDERCardiac disorders | 1/283 |
| MYOCARDIAL INFARCTIONCardiac disorders | 1/283 |
| PROSTATE CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/283 |
| RENAL CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/283 |
| CHOLECYSTITIS ACUTEHepatobiliary disorders | 1/283 |
| URINARY RETENTIONRenal and urinary disorders | 1/283 |
| Event | Advanced PCa |
|---|---|
| NASOPHARYNGITISInfections and infestations | 31/283 |
| BRONCHITISInfections and infestations | 16/283 |
| DISEASE PROGRESSIONGeneral disorders | 13/283 |
| HOT FLUSHVascular disorders | 12/283 |
| GYNAECOMASTIAReproductive system and breast disorders | 6/283 |
| FATIGUEGeneral disorders | 5/283 |
| DERMATITISSkin and subcutaneous tissue disorders | 5/283 |
| BREAST ENLARGEMENTReproductive system and breast disorders | 4/283 |
| GASTRITISGastrointestinal disorders | 3/283 |
| DIABETES MELLITUSMetabolism and nutrition disorders | 3/283 |
Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of Leuprorelin.
| Age, Continuous(Years) | Advanced PCa |
|---|---|
| Mean | 65.4 ± 6.3 |
| Sex: Female, Male(Participants) | Advanced PCa |
|---|---|
| Female | 0 |
| Male | 283 |
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AbbVie (prior sponsor, Abbott)