A Phase 4 interventional study of Triptorelin 11.25 mg in Prostate Cancer, sponsored by Ipsen. Completed at 18 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by Ipsen · Phase 4, Interventional, and Treatment
The purpose of this study is to assess the benefit of immediate hormonal treatment after Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months
This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 226 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Ipsen is the lead sponsor of 282 studies on the registry; 16 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 19 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score)
Exclusion Criteria:
Triptorelin, powder and solvent for suspension (prolonged released form)
Drug: Triptorelin 11.25 mg
Active surveillance after radical prostatectomy (RP)
Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)
Number of Subjects With BR Events
The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later.
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Median Time to BRFS
BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or first quartile (Q1) (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports median time to BRFS (with Q1 time to BRFS reported in the subsequent outcome measure).
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Q1 Time to BRFS
BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports Q1 time to BRFS.
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Median Time to Event-Free Survival (EFS)
EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports median time to EFS (with Q1 time to EFS reported in the subsequent outcome measure).
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Q1 Time to EFS
EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports Q1 time to EFS.
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Median Time to Overall Survival (OS)
OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports median time to OS (with Q1 time to OS reported in the subsequent outcome measure).
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Q1 Time to OS
OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports Q1 time to OS.
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Time to Disease-specific Mortality
Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer.
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Median Time to PSA Doubling Time (PSADT)
PSADT was defined as the time from the first documented PSA increase \>0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports median time to PSADT (with Q1 time to PSADT reported in the subsequent outcome measure).
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Q1 Time to PSADT
PSADT was defined as the time from the first documented PSA increase \>0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports Q1 time to PSADT.
Time frame: Baseline (Day 1) and every 3 months until end of study with final analysis performed after required 61 BRs were observed on global study level. Minimum monitoring period of 36 months for each subject; maximum duration of 78 months (last subject censored).
Percent Change From Baseline in PSA Levels
As per inclusion criterion, all subjects in both treatment groups had PSA levels ≤0.2 ng/mL at the screening visit. Starting from Month 3, any elevated PSA concentration \>0.2 ng/mL had to be confirmed by a second measurement performed 4 to 6 weeks later. No confirmation test was required after evidence of disease progression (BR and/or clinical disease progression). Subjects remained in the study until Month 36, even if they had a biochemical failure (PSA levels \>0.2 ng/mL); then they could enter follow-up. The percent change from baseline was defined as the percent change from the screening visit (Day -14). Percent change from baseline in PSA levels are reported as median values at Months 3, 6, 9, 12, 24 and 36. Note: the raw baseline values for PSA levels are reported in the Baseline Characteristics section.
Time frame: Screening (Day -14) and Months 3, 6, 9, 12, 24 and 36.
Change From Baseline in Serum Testosterone Levels
Serum testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline and at 3, 6 and 9 months only in subjects in the triptorelin arm. Change from baseline in testosterone levels are reported as median values at Months 3, 6 and 9. Note: the raw baseline values for testosterone levels are reported in the Baseline Characteristics section.
Time frame: Baseline (Day 1) and Months 3, 6 and 9.
Change From Baseline in FACT-P Total Score
Health-Related Quality of Life (HRQoL) was assessed using the FACT-P questionnaire (v4) at baseline and at 9, 24 and 36 months. The FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life. Change from baseline in FACT-P total score are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for FACT-P total score are reported in the Baseline Characteristics section.
Time frame: Baseline (Day 1) and Months 9, 24 and 36.
Change From Baseline in SF-36 Physical and Mental Component Summary Measures Norm-Based Scores (i.e. PCS and MCS)
HRQoL was assessed using the SF-36 health survey (v2) at baseline and at 9, 24 and 36 months. The 36 items cover 8 health domains: PF, role-physical, BP, SF, MH, RE, VT and GH. Subscale scores were normed to the 2009 US general population (mean=50; SD=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. Change from baseline in SF-36 PCS and MSC norm-based scores are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for PCS and MSC norm-based scores are reported in the Baseline Characteristics section.
Time frame: Baseline (Day 1) and Months 9, 24 and 36.
The study was conducted in male subjects with high-risk prostate cancer who had undergone radical prostatectomy (RP) in 18 sites in China and Russia between Dec 2012 and Sep 2019. The study participation for each subject was at least 36 months. The end of study was when 61 biochemical relapse (BR) events were observed on the study global level.
| Milestone | Active Surveillance | Triptorelin |
|---|---|---|
| Started | 117 | 109 |
| Received triptorelin treatment | 0 | 105 |
| Completed | 76 | 73 |
| Not completed | 41 | 36 |
| Withdrew: Lost to follow-up | 7 | 2 |
| Withdrew: Withdrawal by subject | 26 | 23 |
| Withdrew: Adverse event (up to month 36) | 1 | 1 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Did not attend end of study visit | 7 | 8 |
The primary efficacy analyses of Biochemical Relapse-Free Survival (BRFS) was performed after 61 BR events were observed on the study global level. The number of subjects with BR events per treatment group is reported. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later.
| Participants | Active Surveillance | Triptorelin |
|---|---|---|
| Number of Subjects With BR Events | 35 | 26 |
BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or first quartile (Q1) (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports median time to BRFS (with Q1 time to BRFS reported in the subsequent outcome measure).
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Median Time to BRFS | NA (NA to NA) | NA (NA to NA) |
BRFS was defined as the time from randomisation to time of BR. The definition of BR was increased PSA \>0.2 ng/mL confirmed by a second measurement performed 4 to 6 weeks later. The time point at which the first elevated PSA measurement \>0.2 ng/mL was recorded was deemed to be the time of BR. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to BRFS associated with each treatment. This outcome measure reports Q1 time to BRFS.
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Q1 Time to BRFS | 30.0 (18.6 to 42.1) | 39.1 (29.9 to NA) |
EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports median time to EFS (with Q1 time to EFS reported in the subsequent outcome measure).
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Median Time to Event-Free Survival (EFS) | NA (NA to NA) | NA (NA to NA) |
EFS was defined as the time from randomisation to time of first clinical disease progression or death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to EFS associated with each treatment. This outcome measure reports Q1 time to EFS.
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Q1 Time to EFS | NA (NA to NA) | NA (NA to NA) |
OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports median time to OS (with Q1 time to OS reported in the subsequent outcome measure).
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Median Time to Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) |
OS was defined as the time between randomisation and death from any cause. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) time to OS associated with each treatment. This outcome measure reports Q1 time to OS.
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Q1 Time to OS | NA (NA to NA) | NA (NA to NA) |
Disease-specific mortality was measured as the time between randomisation and death related to prostate cancer.
No measurements were reported for this outcome.
PSADT was defined as the time from the first documented PSA increase \>0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports median time to PSADT (with Q1 time to PSADT reported in the subsequent outcome measure).
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Median Time to PSA Doubling Time (PSADT) | NA (15.2 to NA) | NA (9.1 to NA) |
PSADT was defined as the time from the first documented PSA increase \>0.2 ng/mL to the time of the first value more than twice that of the first increased value. The Kaplan-Meier method was used to obtain the estimates of median and/or Q1 (if median was not reached) PSADT associated with each treatment. This outcome measure reports Q1 time to PSADT.
| months | Active Surveillance | Triptorelin |
|---|---|---|
| Q1 Time to PSADT | 13.4 (6.0 to NA) | 9.1 (1.6 to NA) |
As per inclusion criterion, all subjects in both treatment groups had PSA levels ≤0.2 ng/mL at the screening visit. Starting from Month 3, any elevated PSA concentration \>0.2 ng/mL had to be confirmed by a second measurement performed 4 to 6 weeks later. No confirmation test was required after evidence of disease progression (BR and/or clinical disease progression). Subjects remained in the study until Month 36, even if they had a biochemical failure (PSA levels \>0.2 ng/mL); then they could enter follow-up. The percent change from baseline was defined as the percent change from the screening visit (Day -14). Percent change from baseline in PSA levels are reported as median values at Months 3, 6, 9, 12, 24 and 36. Note: the raw baseline values for PSA levels are reported in the Baseline Characteristics section.
| percent change | Active Surveillance | Triptorelin |
|---|---|---|
| Month 3 | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
| Month 6 | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
| Month 9 | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
| Month 12 | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
| Month 24 | 0.0 (0.0 to 0.0) | 0.0 (0.0 to 0.0) |
| Month 36 | 0.0 (0.0 to 25.7) | 0.0 (0.0 to 0.0) |
Serum testosterone levels were evaluated on blood samples taken before triptorelin injection at baseline and at 3, 6 and 9 months only in subjects in the triptorelin arm. Change from baseline in testosterone levels are reported as median values at Months 3, 6 and 9. Note: the raw baseline values for testosterone levels are reported in the Baseline Characteristics section.
| ng/dL | Triptorelin |
|---|---|
| Month 3 | -444.60 (-599.30 to -305.20) |
| Month 6 | -438.80 (-599.45 to -306.15) |
| Month 9 | -429.80 (-573.90 to -304.00) |
Health-Related Quality of Life (HRQoL) was assessed using the FACT-P questionnaire (v4) at baseline and at 9, 24 and 36 months. The FACT-P score is composed of 27 general questions about physical, social, emotional, and functional well-being, as well as a 12-item questionnaire about prostate-specific concerns. The total FACT-P score was calculated as the sum of 39 item scores (range of 0-156); higher scores indicate a better quality of life. Change from baseline in FACT-P total score are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for FACT-P total score are reported in the Baseline Characteristics section.
| score on a scale | Active Surveillance | Triptorelin |
|---|---|---|
| Month 9 | 4.75 (0.79 to 8.70) | 0.88 (-3.04 to 4.79) |
| Month 24 | 1.48 (-2.86 to 5.83) | 3.78 (0.22 to 7.33) |
| Month 36 | 2.76 (-1.96 to 7.49) | 3.81 (-1.05 to 8.67) |
HRQoL was assessed using the SF-36 health survey (v2) at baseline and at 9, 24 and 36 months. The 36 items cover 8 health domains: PF, role-physical, BP, SF, MH, RE, VT and GH. Subscale scores were normed to the 2009 US general population (mean=50; SD=10) to give norm-based scores. Two summary measures were then calculated: PCS was derived from PF, role-physical, BP and GH; MCS was derived from SF, MH, RE and VT. The PCS and MCS norm-based scores ranged 0-100; higher scores indicate a better QoL. Change from baseline in SF-36 PCS and MSC norm-based scores are reported as mean values at Months 9, 24 and 36. A negative change from baseline indicates decreased QoL. Note: the raw baseline values for PCS and MSC norm-based scores are reported in the Baseline Characteristics section.
| score on a scale | Active Surveillance | Triptorelin |
|---|---|---|
| PCS: Month 9 | 2.78 (1.23 to 4.34) | 2.60 (1.22 to 3.98) |
| PCS: Month 24 | 4.49 (2.91 to 6.06) | 3.46 (1.87 to 5.04) |
| PCS: Month 36 | 4.79 (3.11 to 6.46) | 4.86 (3.15 to 6.56) |
| MCS: Month 9 | 1.80 (-0.35 to 3.95) | 4.26 (2.23 to 6.28) |
| MCS: Month 24 | 0.55 (-1.67 to 2.77) | 2.81 (0.69 to 4.93) |
| MCS: Month 36 | 1.13 (-1.35 to 3.61) | 5.10 (2.89 to 7.31) |
Collected over Up to 12 months for the reporting groups 'Prior to Month 12'; up to 24 months for the reporting group 'Posterior to Month 12'. For the triptorelin arm, treatment-emergent adverse events (TEAEs) are reported. For the active surveillance arm, all adverse events (AEs) are reported (TEAEs were not applicable for this arm; all AEs were considered as non-treatment emergent since subjects did not receive any triptorelin injections).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Surveillance - Safety Population - Prior to Month 12 | 1/112 (0.9%) | 11/112 (9.8%) | 27/112 (24.1%) |
| Triptorelin - Safety Population - Prior to Month 12 | 0/105 (0%) | 3/105 (2.9%) | 31/105 (29.5%) |
| Overall Safety Population - Posterior to Month 12 | 2/217 (0.9%) | 2/217 (0.9%) | 7/217 (3.2%) |
| Event | Active Surveillance - Safety Population - Prior to Month 12 | Triptorelin - Safety Population - Prior to Month 12 | Overall Safety Population - Posterior to Month 12 |
|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 0/112 | 1/105 | 0/217 |
| Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/112 | 1/105 | 0/217 |
| Urethral stenosisRenal and urinary disorders | 1/112 | 1/105 | 0/217 |
| Inguinal hernia, obstructiveGastrointestinal disorders | 1/112 | 0/105 | 0/217 |
| Salivary gland calculusGastrointestinal disorders | 1/112 | 0/105 | 0/217 |
| Bone neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/112 | 0/105 | 0/217 |
| Varicose veinVascular disorders | 1/112 | 0/105 | 0/217 |
| Incisional herniaInjury, poisoning and procedural complications | 1/112 | 0/105 | 0/217 |
| Haemangioma of liverNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/112 | 0/105 | 0/217 |
| Inguinal herniaGastrointestinal disorders | 1/112 | 0/105 | 0/217 |
| Event | Active Surveillance - Safety Population - Prior to Month 12 | Triptorelin - Safety Population - Prior to Month 12 | Overall Safety Population - Posterior to Month 12 |
|---|---|---|---|
| Hot flushVascular disorders | 0/112 | 10/105 | 0/217 |
| NasopharyngitisInfections and infestations | 4/112 | 4/105 | 2/217 |
| Aspartate aminotransferase increasedInvestigations | 0/112 | 2/105 | 0/217 |
| Platelet count decreasedInvestigations | 2/112 | 2/105 | 0/217 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/112 | 2/105 | 0/217 |
| FatigueGeneral disorders | 1/112 | 2/105 | 0/217 |
| PyrexiaGeneral disorders | 1/112 | 2/105 | 0/217 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 0/112 | 2/105 | 0/217 |
| ConstipationGastrointestinal disorders | 2/112 | 0/105 | 1/217 |
| Micturition urgencyRenal and urinary disorders | 2/112 | 0/105 | 0/217 |
Intention-to-Treat (ITT) population consisted of all randomised subjects analysed according to the group to which they were randomised (i.e. regardless of treatment approach followed).
| Age, Continuous(years) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Mean | 65.3 ± 6.8 | 65.4 ± 6.1 | 65.3 ± 6.4 |
| Sex: Female, Male(Participants) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 117 | 109 | 226 |
| Race/Ethnicity, Customized(Participants) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Asian | 84 | 79 | 163 |
| Caucasian / White | 33 | 30 | 63 |
| Region of Enrollment(Participants) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| China | 84 | 79 | 163 |
| Russia | 33 | 30 | 63 |
| PSA Levels(ng/mL) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Median | 0.074 (0.074 to 0.074) | 0.074 (0.074 to 0.074) | 0.074 (0.074 to 0.074) |
| Testosterone Levels(nanograms per deciliter (ng/dL)) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Median | — | 462.00 (333.00 to 612.00) | 462.00 (333.00 to 612.00) |
| Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score(scores on a scale) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Mean | 113.26 ± 18.64 | 114.98 ± 18.31 | 114.08 ± 18.46 |
| 36-Item Short Form Health Survey (SF-36) Score(scores on a scale) | Active Surveillance | Triptorelin | Total |
|---|---|---|---|
| Physical Component Summary (PCS) | 46.31 ± 6.49 | 47.37 ± 6.62 | 46.81 ± 6.56 |
| Mental Component Summary (MCS) | 48.18 ± 9.78 | 47.41 ± 9.59 | 47.81 ± 9.67 |
1 further baseline measures are reported on the registry.
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