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Keywords:

  • prostate cancer;
  • image guided radiotherapy;
  • Trifecta;
  • SCP;
  • hypofractionation;
  • urinary incontinence;
  • erectile dysfunction

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Objective

  • To report the image-guided hypofractionated radiotherapy (hypo-IGRT) outcome for patients with localised prostate cancer according to the new outcome models Trifecta (cancer control, urinary continence, and sexual potency) and SCP (failure-free survival, continence and potency).

Patients and Methods

  • Between August 2006 and January 2011, 337 patients with cT1–T2N0M0 prostate cancer (median age 73 years) were eligible for a prospective longitudinal study on hypo-IGRT (70.2 Gy/26 fractions) in our Department.
  • Patients completed four questionnaires before treatment, and during follow-up: the International Index of Erectile Function-5 (IIEF-5), the International Prostate Symptom Score (IPSS), and the European Organization for Research and Treatment of Cancer prostate-cancer-specific Quality of Life Questionnaires (QLQ) QLQ-PR25 and QLQ-C30.
  • Baseline and follow-up patient data were analysed according to the Trifecta and SCP outcome models. Cancer control, continence and potency were defined respectively as no evidence of disease, score 1 or 2 for item 36 of the QLQ-PR25 questionnaire, and total score of >16 on the IIEF-5 questionnaire.
  • Patients receiving androgen-deprivation therapy (ADT) at any time were excluded.

Results

  • Trifecta criteria at baseline were met in 72 patients (42% of all ADT-free patients with completed questionnaires).
  • Both at 12 and 24 months after hypo-IGRT, 57% of the Trifecta patients at baseline were still meeting the Trifecta criteria (both oncological and functional success according to the SCP model).
  • The main reason for failing the Trifecta criteria during follow-up was erectile dysfunction: in 18 patients after 6 months follow-up, in 12 patients after 12 months follow-up, and in eight patients after 24 months.
  • Actuarial 2-year Trifecta failure-free survival rate was 44% (95% confidence interval 27–60%).
  • In multivariate analysis no predictors of Trifecta failure were identified. Missing questionnaires was the main limitation of the study.

Conclusion

  • The Trifecta and SCP classifications can be used as tools to report RT outcome.

Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Radiotherapy (RT) is one of the well-established treatment approaches in localised prostate cancer [1]. Recent improvement in understanding the biology of prostate cancer (high sensitivity to a high-fraction dose) and the availability of high precision RT (image-guided RT, IGRT) have allowed the designing of hypofractionated schedules, with reduced treatment toxicity, increased tumour control rates, and improved patient compliance [2-5].

Treatment choice for organ-confined prostate cancer is based on well-known prognostic factors, i.e. initial PSA level, stage of disease, Gleason score, patient general conditions, comorbidities, and patient age [1]. Obviously, patient preference plays an essential role in the therapeutic decision. While discussing with the patient potential benefits and risks of available approaches, multiple concomitant endpoints must considered, including cancer cure, functional outcome (urinary continence, sexual potency) and treatment toxicity.

Only recently the Trifecta criteria (cancer control, urinary continence, and sexual potency) have been introduced to report treatment outcome in different surgical series [6, 7]. In the pivotal study of Bianco et al. [6], including data on 1746 patients that underwent nerve-sparing radical prostatectomy (RP), by 2 years after RP 60% of men were continent, potent and cancer free. This methodology is only applicable to the preoperatively continent and potent patients who had received bilateral nerve-sparing RP. To overcome the limitation of pre-treatment dysfunctions, the SCP criteria (failure-free survival, continence and potency, all grouped in various combinations) were designed by Ficarra et al. [7].

Our aim was to report patient outcome by means of the new models Trifecta and SCP, and assess the number of patients achieving ideal Trifecta and SCP outcomes after hypofractionated-IGRT (hypo-IGRT) for localised prostate cancer. To the best of our knowledge, this is the first study reporting on patient outcome either with the Trifecta or the SCP models in a series of patients with prostate cancer treated with RT.

In our Department, three IGRT methods were installed in 2006: ultrasound-based b-mode acquisition and targeting system (BATTM, NOMOS, Cranberry Township, PA, USA), stereo X-ray imaging system coupled with the six-degree of freedom robotic couch (ExacTracTM, BrainLAB, Feldkirchen, Germany), and cone-beam CT (CBCT, On Board Imager OBITM, Varian Medical System, Palo Alto, CA, USA). Taking advantage of these technologies, hypo-IGRT schemes for organ-confined prostate cancer were implemented. The Fox Chase hypofractionated regimen of 70.2 Gy/26 fractions of 2.7 Gy, biologically equivalent to our standard schedule, was adopted for treatment. Assuming a prostate cancer α/β ratio of 1.5 Gy, this schedule is biologically equivalent to 84.24 Gy in 2.0 Gy fractions [8]. These new approaches, i.e. image guidance and hypofractionation, are commonly used in modern RT for prostate cancer. Combined outcome evaluation is warranted in order to compare novel treatment methods (mini-invasive surgery, high precision RT) and facilitate the patient's and physician's decision on the treatment choice based on the individual patient and tumour characteristics.

The present study was undertaken based on the availability of both tumour control and prospective functional assessment data through health-related quality of life (HRQL) questionnaires. The data on acute toxicity and HRQL in the patient series under investigation have been recently published [9, 10].

Patients and Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

A series of 337 patients with localised prostate cancer were prospectively enrolled for hypo-IGRT in our Department [9, 10]. The present analysis was undertaken to assess the compliance to Trifecta and SCP criteria for treated patients with prostate cancer at baseline and at 6, 12, and 24 months after hypo-IGRT. The study was notified to the Ethical Committee of the European Institute of Oncology (EIO), Milan, Italy.

Inclusion Criteria and Hypo-IGRT

Inclusion criteria, patient preparation protocol, RT simulation, contouring details, dose prescription, dose volume histograms constraints and IGRT systems have been described elsewhere [9, 10]. In brief, the eligible patients were men with organ-confined prostate cancer (cT1–2 N0 M0) with satisfactory urinary flow and no significant comorbidity. Androgen-deprivation therapy (ADT) was permitted for intermediate- and high-risk patients.

All patients were treated with two dynamic lateral three-dimensional conformal arcs (BrainScanTM v. 5.31, BrainLAB, Feldkirchen, Germany), and the ERGO 3D-LineTM treatment planning system was used. The dose of 70.2 Gy/26 fractions was prescribed at the International Commission of Radiation Units point [11]. No elective pelvic lymph node irradiation was performed.

Daily target localisation was performed using one of the three methods: BAT, ExacTrac, or CBCT.

Assessment of Toxicity, Tumour Control and HRQL Data

During hypo-IGRT all patients were visited by a radiation oncologist once a week, and every 6 months during follow-up. Patients completed four questionnaires, before treatment, and at 6, 12 and 24 months afterwards: the European Organization for Research and Treatment of Cancer (EORTC) prostate-cancer-specific QLQ-PR25 and QLQ-C30, the IPSS, and the International Index of Erectile Function-5 (IIEF-5). Permission to use the EORTC questionnaires was obtained from the EORTC Quality of Life Group.

Trifecta and SCP Criteria

Cancer control, urinary continence and sexual potency were defined respectively as no evidence of disease (American Society for Radiation Oncology, ASTRO definition of biochemical failure) [12], score 1 or 2 for item 36 of the QLQ-PR25, and a score of >16 in the IIEF-5. The same definitions were used both for Trifecta and SCP analyses.

Patients receiving ADT at any time were not considered in the analysis, in order to exclude patients with ADT-induced erectile dysfunction (ED).

Statistical Analysis

Continuous data were summarised as the mean and standard deviation, or median and range, while categorical variables were summarised as frequency tables. Patients meeting Trifecta criteria at baseline were compared with those not meeting Trifecta criteria. Comparison between characteristics of the two populations was performed by the Pearson's chi square in case of categorical variables, and by the t-test or Wilcoxon-Mann–Whitney test for continuous variables, based on the normality assumption of the distribution. Comparison of categorical variables based on ordinal scale was performed by the Mantel–Haenszel test per trend.

Time-to-event (Trifecta failure) was calculated as the difference between the starting date of the hypo-IGRT and the time of any of the first event among urinary incontinence, loss of sexual potency and disease progression (including biochemical progression), or last known follow-up visit in case of no event.

The actuarial Trifecta failure-free survival rate (probability of maintaining the Trifecta status during follow-up) was estimated by the Kaplan–Meier approach including exclusively the patients who met Trifecta criteria at baseline. Comparison of actuarial Trifecta failure-free survival rate between subgroups was performed by the log-rank test. All variables associated to Trifecta failure at a P < 0.10 were considered for multivariate analysis according to the Cox-regression model.

Patients were ranked in SCP categories according to Ficarra et al. [7]. Statistical analyses were performed using SAS statistical software (version 9.2 for Windows).

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Table 1 describes the characteristics of the 337 consecutive patients with prostate cancer treated with hypo-IGRT between August 2006 and January 2011 in our Department.

Table 1. Patients' characteristics in Trifecta and non-Trifecta patients at baseline
CharacteristicsNo TrifectaTrifectaAll patientsP*
  1. *Pearson chi-square; ** t-test; ***test per trend; Wilcoxon's test.

Number of patients15372225 
Mean (sd) age, years71.9 (6.2)69.4 (6.9)71.0 (6.5)0.007**
N (%)    
Age (years):    
≤6524 (16.0)20 (27.8)44 (19.8)0.01***
65–7025 (16.7)16 (22.2)41 (18.5)
70–7554 (36.0)21 (29.2)75 (33.8)
>7547 (31.3)15 (20.8)62 (27.9)
unknown303
T stage:   0.22
T1106 (69.3)44 (61.1)150 (66.7)
T247 (30.7)28 (38.9)75 (33.3)
N stage:   0.41
N0148 (96.7)71 (98.6)219 (97.3)
Nx5 (3.3)1 (1.4)6 (2.7)
Gleason score, median (range)    
 N (%):6 (4–9)6 (3–8)6 (3–9)0.17
≤58 (5.2)3 (4.2)11 (4.9)0.22***
693 (60.8)38 (53.5)131 (58.5)
745 (29.4)25 (35.2)70 (31.2)
8–107 (4.6)5 (7.1)12 (5.4)
unknown011
Initial PSA level ng/mL, median (range)    
 N (%):6.2 (1.2–33.5)6.0 (0.6–43)6.1 (0.6–43)0.79
≤418 (11.8)10 (13.9)28 (12.4)0.98***
4–10107 (69.9)50 (69.4)157 (69.8)
10–2027 (17.6)9 (12.5)36 (16.0)
>201 (0.6)3 (4.2)4 (1.8)
N (%):    
NCCN risk group:   0.74
low83 (54.2)37 (52.1)120 (53.6)
intermediate63 (41.2)29 (40.8)92 (41.1)
high7 (4.6)5 (7.1)12 (5.4)
RT volume:   0.33
prostate87 (56.9)36 (50.0)123 (54.7)
prostate + seminal vesicles66 (43.1)36 (50.0)102 (45.3)
Concomitant diseases:129 (84.3)58 (80.6)187 (83.1)0.48
diabetes mellitus19 (12.4)5 (6.9)24 (10.7)0.21
cardiopathy26 (17.0)15 (20.8)41 (18.2)0.49
arterial hypertension63 (41.2)18 (25.0)81 (36.0)0.02
vascular disease11 (7.2)3 (4.2)14 (6.2)0.38
colon diverticulosis5 (3.3)1 (1.4)6 (2.7)0.41
other neoplasia7 (4.6)4 (5.6)11 (4.9)0.75
dyslipidaemia8 (5.2)2 (2.8)10 (4.4)0.40
other diseases88 (57.5)42 (58.3)130 (57.8)0.90
IGRT method:   0.11
BAT107 (69.9)54 (75.0)161 (71.6)
ExacTrac26 (17.0)15 (20.8)41 (18.2)
CBCT20 (13.1)3 (4.2)23 (10.2)
Year of IGRT:   0.20
200610 (6.5)010 (4.4)
200737 (24.2)19 (26.4)56 (24.9)
200837 (24.2)20 (27.8)57 (25.3)
200937 (24.2)22 (30.5)59 (26.2)
201030 (19.6)11 (15.3)41 (18.2)
20112 (1.3)02 (0.9)

All patients completed the planned treatment, and there was only limited acute and late toxicity [9, 10]. The median duration of hypo-IGRT was 38 days. Patient follow-up was updated to at least the time of last questionnaire administration, with a median (range) follow-up of 19 (1–51) months.

Trifecta and SCP Criteria

Baseline QLQ-C30, QLQ-PR25 and IPSS were available for 290 (86%), 282 (84%) and 300 (89%) patients, respectively. IIEF-5 was available for 275 (82%) patients, 189 (56%) when excluding those with ADT at baseline.

At baseline, after the consecutive exclusion of 112, 54, 2 and 97 patients due respectively to ADT, missing questionnaires, urinary incontinence and ED, Trifecta criteria were met in 72 patients (42% of all ADT-free patients with completed questionnaires). Only this patient subgroup has been taken into consideration for further analysis in this publication (Fig. 1) according to the Trifecta and SCP models.

figure

Figure 1. Flow chart with patients' baseline and follow-up data. NED, no evidence of disease; QLQ-PR25, EORTC prostate cancer-specific QLQ; pts, patients.

Download figure to PowerPoint

Considering the ADT-free population of 225 patients, we first compared the characteristics of the subgroup that met the Trifecta criteria (72 patients) vs the subgroup that did not meet the same criteria at baseline (153). Patients meeting Trifecta outcome were significantly younger (P = 0.01) and had fewer concomitant disorders (arterial hypertension; P = 0.02; Table 1). There were no other differences between the two subgroups.

At 6 months after hypo-IGRT, 51 patients were eligible for the analysis (21 excluded due to missing questionnaires), and 33 met Trifecta criteria (65%). At 12 months after hypo-IGRT, 30 patients were eligible for analysis (42 excluded due to missing questionnaires), and 17 met Trifecta outcome (57%). At 24 months after hypo-IGRT, 21 patients were eligible (51 excluded due to missing questionnaires), and 12 met Trifecta criteria (57%).

The main reason for failing the Trifecta criteria during follow-up was ED in 18 patients after 6 months, recorded in 12 patients after 12 months and in eight patients after 24 months. Biochemical progression occurred in two patients during follow-up.

The median (range) follow-up of the Trifecta group was 7 (0–30) months. During the follow-up period, 26 patients failed to maintain the Trifecta status, mainly due to moderate-to-severe ED (Table 2), two had biochemical progression, and one incontinence.

Table 2. Follow-up data in Trifecta patients at baseline (N = 72 patients)
CharacteristicsValue
  1. *Loss of sexual potency, urinary incontinence or biochemical recurrence.

N72
Median (range) follow-up duration, months7 (0–30)
N (%): 
Events during follow-up: 
loss of sexual potency26 (36.1)
urinary incontinence1 (1.4)
biochemical recurrence2 (2.8)
Trifecta: 
success (potent, continent, no biochemical recurrence)46 (63.9)
failure*26 (36.1)
Median (range) time to median Trifecta failure, months13 (10–∞)
Median (range) time elapsed between RT and recurrence, months (N = 26)6 (3–25)

The actuarial Trifecta failure-free survival rate at 24 months after hypo-IGRT was 44% (95% CI: 27–60%; Fig. 2). Table 3 shows a lower probability of Trifecta failure at univariate analysis in younger patients, in those treated with ExacTrac or CBCT IGRT verification system, and those with high-risk prostate cancer according to the National Comprehensive Cancer Network (NCCN) guidelines [13]. However, no predictors for Trifecta failure were found at multivariate analysis.

figure

Figure 2. Actuarial Trifecta failure-free survival (TFFS) rate curve (in patients meeting Trifecta criteria at baseline, N = 72).

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Table 3. Predictors of Trifecta failure-free survival rate in continent and potent patients at baseline
VariablesTotal, nUnivariateMultivariate
Events, n (%)Event-free survival, %P (log-rank)OR (95% CI)P (Wald chi squared)
  1. *One patient with missing data. iPSA, initial PSA level; ves, vesicles.

All patients722637   
IGRT method:   0.038  
BAT5421 (38.9)27.61 
ExacTrac185 (27.8)51.70.41 (0.14–1.16)0.09
Age, years:   0.047  
≤70368 (22.2)46.81 
>703618 (50.0)34.21.62 (0.65–4.02)0.30
Gleason Score*:   0.025  
≤64115 (36.6)29.9
=7257 (28.0)54.1
8–1054 (80)0
T stage:   0.88  
T14415 (34.1)39.7
T22811 (39.3)30.9
iPSA, ng/mL:   0.35  
≤106022 (36.7)36.4
>10124 (33.3)35.7
NCCN risk group*:   0.07  
low3714 (37.8)30.91 
intermediate299 (31.0)48.51.03 (0.43–2.48)0.95
high53 (60.0)03.61 (0.91–14.41)0.07
RT volume:   0.35  
prostate3612 (33.3)37.5
prostate+seminal ves3614 (38.9)32.3
Concomitant diseases:   0.18  
no143 (21.4)40.0
yes5823 (39.7)35.8

In Table 4 we have ranked the same 171 patients not receiving ADT and with completed questionnaires according to the SCP criteria: 72 patients were potent and continent before hypo-IGRT (Trifecta at baseline), 98 had ED before hypo-IGRT (Px), and two were incontinent before hypo-IGRT (Cx). Most of the Trifecta patients at baseline were in the S0 C0 P0 category or had missing data at questionnaires at both 6 (45.8% and 29.2%, respectively) and 12 months follow-up (23.6% and 59.8%). At 6 months follow-up 25% of potent and continent patients before treatment had oncological success and functional failure (S0 C0 P1) and at 24 months 16.7%.

Table 4. Simplified SCP criteria [7] at 6 months or 1 year after hypo-IGRT (N = 171)
ResultsPotent and continent before hypo-IGRTED before hypo-IGRT (Px)Incontinent before hypo-IGRT (Cx)
SCPN = 72SCPN = 98*SCPN = 2*
n (%)n (%)n (%)
  1. *One patient with both ED and incontinent before hypo-IGRT. S0, biochemical control; S1, biochemical failure; Px, sexual potency not evaluable; P0, sexual potency preserved; P1, ED; Cx, urinary continence not evaluable; C0, urinary continence preserved; C1, urinary incontinence (see text for definitions of endpoints).

6-month follow-up      
Oncological and functional successS0 C0 P033 (45.8)S0 C056 (57.2)S0 P01 (50.0)
Oncological success and functional failureS0 C1 P00S0 C11 (1.0)S0 P10
S0 C0 P118 (25.0)
Oncological failure and functional successS1 C0 P00S1 C00S1 P00
Oncological and functional failureS1 C1 P00S1 C10S1 P10
S1 C0 P10
S1 C1 P10
Questionnaires not completed 21 (29.2) 41 (41.8) 1 (50.0)
12-month follow-up      
Oncological and functional successS0 C0 P017 (23.6)S0 C040 (40.8)S0 P01 (50.0)
Oncological success and functional failureS0 C1 P00S0 C11 (1.0)S0 P10
S0 C0 P112 (16.7)
Oncological failure and functional successS1 C0 P00S1 C01 (1.0)S1 P00
Oncological and functional failureS1 C1 P00S1 C10 (-)S1 P10
S1 C0 P10
S1 C1 P10
Questionnaires not completed 43 (59.7) 56 (57.2) 1 (50.0)

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

The present study, including data on 337 patients with localised prostate cancer treated with hypo-IGRT, showed that by the 2-year follow-up, 57% of pretreatment continent and potent men were cancer free and still continent and potent. This outcome data is surprisingly similar to the outcome reported for surgical series (mean rate of 57% in 11 surgical series with follow-up duration similar to the present study) [7], despite heterogeneous patient characteristics, various definitions of ED and urinary incontinence, and assessment methods. Actuarial probability of achieving ideal Trifecta outcome after 2 years was 44%.

The strengths of the present study include the large patient cohort treated with modern RT methods over a short period at a single institution, and the prospective longitudinal HRQL evaluation at baseline and up to 2 years after the end of the treatment. Validated patient-reported self-administered questionnaires were used. Actuarial analysis and multivariate tests were performed.

At the same time, we are well aware of the limitations of the present study, including use of surgery-specific endpoints, relatively low number of evaluable patients, intrinsic features of the Trifecta and SCP tools and short median follow-up. Although we need to confirm the present data over a longer time scale, the 2-year follow-up might be considered sufficient for this preliminary evaluation, as many surgical series report results over even shorter follow-up periods [7]. From the point of view of outcome evaluation, longer follow-up would allow for the inclusion of the high- and intermediate-risk patients treated with concomitant ADT (given for a maximum of 2–3 years) that have been excluded from the present study. Then, Trifecta at 4 or 5 years after hypo-IGRT would allow evaluation of potency recovery and long-term outcome in patients with more aggressive prostate cancer.

The evaluation of outcome in oncology is a difficult issue. Multiple endpoints must be considered both for tumour control and treatment complications. For many years the priority on the treatment choice had been given to tumour control probability, and only recently the burden of side-effects and its impact on the patient HRQL has been included into the global treatment evaluation. It is generally accepted that the treatment choice should be guided by the patient preference and priorities [14].

In the present study, we used the Trifecta methodology to report outcome. This methodology has been introduced for surgical series, and thus includes surgical side-effects [6]. The Trifecta system, and even more so, the recently described Pentafecta system (including margin status and postoperative complications), is only applicable in preoperatively continent and potent patients who receive bilateral nerve-sparing RP, therefore may not be used in most surgical patients [7]. Indeed, in the present series Trifecta criteria could be studied in only 32% of all patients (out of 225 patients without ADT, 1%, 24% and 43% were excluded due to urinary incontinence, missing questionnaires and ED, respectively), similar to the number reported also in another surgical Trifecta series [7]. The main reason for exclusion from the analysis, apart from concomitant ADT (33%), was ED in most of our patients before the beginning of the RT course (57% of otherwise eligible patients, Fig. 1). ED was also the main reason for Trifecta failure during the follow-up period (90% of all events). This might be at least partially explained by the age of the patients included in the series (median age 73 years). Interestingly, age was the only factor associated with post-treatment Trifecta/Pentafecta outcome rates both in the present series and in surgical patients [15].

Trifecta criteria give the same weight to all endpoints. Obviously, the patient and caregiver perception will be different for the treatment that leads to 50% of tumor recurrence and the one related to 50% ED and still Trifecta will have the same rate in both scenarios. To overcome these intrinsic limitations of Trifecta, Ficarra et al. [7] have recently proposed the novel outcome tool SCP, which offers the opportunity to classify all patients who undergo RP according to the oncological and functional outcomes on an individual basis, in a way resembling the TNM staging system. The SCP model allows enlarging the number of evaluable patients, as it ranks also patients not Trifecta at baseline. Furthermore, the SCP model better describes the present series of patients, as patients not achieving ideal Trifecta outcome due to potency loss could still be considered and included in the S0 C0 P1 group (oncological success and functional failure).

The present study showed that the Trifecta rates are similar after nerve-sparing RP and hypo-IGRT. However, one of the limitations of reporting Trifecta outcome in a series of patients treated with RT might be that Trifecta does not take into consideration the most common RT side-effects. In this regard, there are some instruments that have been used specifically to report pelvic RT outcome, like TWIST (time without disease and toxicity) [16]. However, the use of classification tools, such as the Trifecta or SCP models, might be justified by the intention to compare RT series with patients undergoing surgery. Until now, no large modern prospective study comparing surgery and RT for patients with prostate cancer has been published (the results of the just closed for accrual PROTECT [Prostate testing for cancer and Treatment] trial are eagerly awaited), and only retrospective or case-control series are available [17].

In conclusion, the ideal outcome for a series of patients with prostate cancer treated in our Department with hypo-IGRT, i.e. cancer control, urinary continence and sexual potency – the Trifecta outcome, was attained in 57% of pretreatment continent and potent patients after 24 months follow-up. Post-treatment ED was the main reason for Trifecta failure during follow-up in baseline sexually active patients. The Trifecta and SCP models can be used to report patient outcome after treatment with RT.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Barbara A. Jereczek-Fossa performed the literature search, study design, data collection and analysis, manuscript writing and final approval of the manuscript; Luigi Santoro: data analysis, manuscript writing and final approval of manuscript; Dario Zerini: data collection, manuscript writing and final approval of manuscript; Cristiana Fodor: data collection and analysis, manuscript writing and final approval of manuscript; Barbara Vischioni: data analysis, manuscript writing and final approval of manuscript; Andrea Maucieri, Marianna Alessandra Gerardi: data collection and final approval of manuscript; Andrea Vavassori, Raffaella Cambria, Cristina Garibaldi, Federica Cattani: data collection, manuscript writing and final approval of manuscript; Deliu V. Matei, Gennaro Musi, Ottavio De Cobelli: data collection and analysis, manuscript writing and final approval of manuscript; Roberto Orecchia: study design, data collection and analysis, manuscript writing and final approval of manuscript.

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  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References
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Abbreviations
ADT

androgen-deprivation therapy

CBCT

cone-beam CT; ED, erectile dysfunction

EORTC

European Organization for Research and Treatment of Cancer

HRQL

health-related quality of life

IIEF-5

International Index of Erectile Function-5

NCCN

National Comprehensive Cancer Network

QLQ

quality of life questionnaire

RP

radical prostatectomy

(IG)RT

(image-guided) radiotherapy

hypo-IGRT

hypofractionated-IGRT