Leah Zajdlewicz

Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study.

BACKGROUND The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. METHOD In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Womens Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patients condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. FINDINGS Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74·50 vs 71·10; p=0·09) or 12 weeks post-surgery (83·80 vs 82·50; p=0·48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30·70 vs 32·70; p=0·45) or 12 weeks post-surgery (35·00 vs 38·90; p=0·18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Δ of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0·21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0·052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. INTERPRETATION These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. FUNDING Cancer Council Queensland.

The validity of the distress thermometer in prostate cancer populations

The Distress Thermometer (DT) is widely recommended for screening for distress after cancer. However, the validity of the DT in men with prostate cancer and over differing time points from diagnosis has not been well examined.

A randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer and their female partners

The diagnosis and treatment of prostate cancer is followed by substantive sexual morbidity. The optimal approach for intervening remains unclear.

Defining Young in the Context of Prostate Cancer

The experience of prostate cancer is for most men a major life stress with the psychological burden of this disease falling more heavily on those who are younger. Despite this, being young as it applies to prostate cancer is not yet clearly defined with varied chronological approaches applied. However, men’s responses to health crises are closely bound to life course and masculinities from which social roles emerge. This paper applied qualitative methodology (structured focus groups and semistructured interviews with expert informants) using interpretative phenomenological analysis to define what it means to be young and have prostate cancer. Structured focus groups were held with 26 consumer advisors (men diagnosed with prostate cancer who provide support to other men with prostate cancer or raise community awareness) and health professionals. As well, 15 men diagnosed with prostate cancer and in their 40s, 50s, or 60s participated in semi-structured interviews. Participants discussed the attributes that describe a young man with prostate cancer and the experience of being young and diagnosed with prostate cancer. Chronological definitions of a young man were absent or inconsistent. Masculine constructions of what it means to be a young man and life course characteristics appear more relevant to defining young as it applies to prostate cancer compared with chronological age. These findings have implications for better understanding the morbidities associated with this illness, and in designing interventions that are oriented to life course and helping young men reconstruct their identities after prostate cancer.

Health-related Quality of Life After the Diagnosis of Locally Advanced or Advanced Prostate Cancer: A Longitudinal Study.

Background: Approximately 20% of men with a diagnosis of prostate cancer present with locally advanced or advanced disease. Few studies consider longer-term impact of disease progression and treatment adverse effects on health-related quality of life (QoL) of these men. Objective: Describe changes in health-related QoL over 5 years for men with newly diagnosed locally advanced or advanced prostate cancer. Interventions/Methods: Eighty-one men with locally advanced or advanced prostate cancer referred to the study by their treating urologist completed a self-administered questionnaire assessing distress, cancer-specific distress, decision regret, satisfaction with life, and global and disease-specific health-related QoL. Questionnaires were administered close to diagnosis (baseline), 2, 6, 12, 24, 36, 48, and 60 months’ follow-up. Results: Men were of mean age 68.3 (SD, 7.9) years and at mean of 31.9 (SD, 50.5) days postdiagnosis. The most common treatment received was androgen deprivation therapy (95.1%) or radiation therapy (79%). The proportion of men classified as distressed (Distress Thermometer) ranged from 46.3% (baseline) to 32.6% (60 months). Decrements in physical QoL were found at 2, 6, 12, 24, 36, and 48 months compared with baseline. Life satisfaction ratings were lower at 6 months compared with baseline. Sexual concerns were consistently high across the 5 years (Expanded Prostate Cancer Index Composite <30). Conclusions: In the context of advanced disease, results indicate that health-related QoL fluctuates from diagnosis to 5 years later. A substantial proportion remained distressed at 5-year follow-up. Implications for Practice: Care frameworks supporting ongoing assessment of health-related QoL concerns of men with advanced prostate cancer are needed with a particular focus on sexual adjustment.

Predictors of long-term distress in female partners of men diagnosed with prostate cancer

Female partners of men with prostate cancer (PCa) experience heightened psychological distress; however, long‐term distress for this group is not well described. We examined partners psychological and cancer‐specific distress over 2 years and predictors of change.

Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: 24-month outcomes from a randomised controlled study

BACKGROUND Previous trials have found similar early outcomes after robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy. We report functional and oncological postoperative outcomes up to 24 months after surgery for these two surgical techniques. METHODS In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Womens Hospital (Brisbane, QLD, Australia). Participants were randomly assigned (1:1) to have either robot-assisted laparoscopic prostatectomy or open radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patients surgical treatment. Primary outcomes were urinary function (urinary domain of Expanded Prostate Cancer Index Composite [EPIC]) and sexual function (sexual domain of EPIC and International Index of Erectile Function Questionnaire [IIEF]) at 6 months, 12 months, and 24 months and oncological outcome (biochemical recurrence and imaging evidence of progression). The trial was powered to assess health-related and domain-specific quality-of-life outcomes over 24 months. All analyses were done on a per-protocol basis. The trial was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000661976. FINDINGS Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to robot-assisted laparoscopic prostatectomy and 163 to open radical retropubic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group and 157 in the robot-assisted laparoscopic prostatectomy group proceeded to surgery. At the 24-month follow-up time point, 150 men remained in the robot-assisted laparoscopic prostatectomy group and 146 remained in the open radical retropubic prostatectomy group. Urinary function scores did not differ significantly between robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy at 6 months post-surgery (88·68 [95% CI 86·79-90·58] vs 88·45 [86·54-90·36]; p1<0·0001, p2<0·0001), 12 months post-surgery (90·76 [88·89-92·62] vs 91·53 [90·07-92·98]; p1<0·0001, p2<0·0001), or 24 months post-surgery (91·33 [89·64-93·03] vs 90·86 [89·01-92·70]; p1<0·0001, p2<0·0001). Sexual function scores were not significantly different between robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy at 6 months post-surgery (EPIC: 37·40 [33·60-41·19] vs 38·63 [34·76-42·49], p1=0·0001, p2<0·0001; IIEF: 29·75 [26·66-32·84] vs 29·78 [26·41-33·16], p1<0·0001, p2<0·0001), 12 months post-surgery (EPIC: 42·28 [38·05-46·51] vs 42·51 [38·29-46·72], p1<0·0001, p2<0·0001; IIEF: 33·10 [29·59-36·61] vs 33·50 [29·87-37·13], p1=0·0002, p2<0·0001), or 24 months post-surgery (EPIC: 45·70 [41·17-50·23] vs 46·90 [42·20-51·60], p1=0·0003, p2<0·0001; IIEF: 33·95 [30·11-37·78] vs 33·89 [29·82-37·96], p1=0·0003, p2=0·0004). Equivalence testing on the difference between the proportion of biochemical recurrences between the two groups (13 [9%] in the open radical retropubic prostatectomy group vs four [3%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a prespecified margin of 10%. However, a superiority test showed that the two proportions were significantly different (p=0·0199). Equivalence testing on the proportion of patients who had imaging evidence of progression revealed that the two groups were not significantly different (p=0·2956). INTERPRETATION Robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy yielded similar functional outcomes at 24 months. We advise caution in interpreting the oncological outcomes of our study because of the absence of standardisation in postoperative management between the two trial groups and the use of additional cancer treatments. Clinicians and patients should view the benefits of a robotic approach as being largely related to its minimally invasive nature. FUNDING Cancer Council Queensland.

Health literacy and the health status of men with prostate cancer

To test the Health Literacy Questionnaire (HLQ) in a sample of men with prostate cancer and examine the components of health literacy that are most strongly associated with mental and physical health‐related quality of life in men with prostate cancer.

The 1000 Survivor Study

Background - Primary brain tumours are rare among adults, but patients often experience physical, cognitive, neurological and psychosocial morbidity. Research has documented high rates of unmet supportive care needs among subgroups, such as patients receiving specific treatments or those receiving palliative care, but the needs of patients in the period soon after diagnosis are not known. Aim - To describe the unmet supportive care needs of adults recently diagnosed with primary brain tumours and change in needs over the early diagnosis/treatment period. Methods - A representative population-based sample of 40 patients was recruited approximately three months after diagnosis through a state cancer registry in Queensland, Australia. Patients or carer proxies completed surveys of supportive care needs in six domains (physical/daily living, psychological, patient care and support, sexuality, health system and information needs, and brain tumour-specific needs) at baseline and three months later. Mean supportive care needs scores (scale 0-100, with higher scores indicating higher levels of need) were calculated and compared over time. Results - The highest mean supportive care needs score at each time point was for physical needs (baseline 47.9, SD 26.3), closely followed by psychological needs (baseline 45.8, SD 35.6). Mean scores for other domains ranged from 30.4 to 37.9. Mean scores in all domains except for sexuality significantly declined over time, with the greatest decline for the patient care and support needs domain (mean 15.9 point decrease). Conclusions - Adults with primary brain tumours experience high levels of unmet physical and psychological needs early in the disease trajectory. However, levels of needs, particularly for patient care, decline over time, perhaps with the completion of primary treatments. Further research is needed to confirm these findings in a larger sample and investigate reasons for the decline seen.Programme/Policy Process: Once a VHL develops its activities through a cooperative network of institutions which are users and producers of information, it was essential to structure such a network within the field of cancer control and develop a governance model that could allow its sustainable operation. The model is composed of Executive Secretary, Advisory Committee, Executive Committee and Responsibility Matrix. The institutions which are part of this collaborative network have been selected in order to represent the regional diversity present in Brazil and also the diverse profiles of institutions related to cancer control, such as research, academia, government, scientific societies and organizations representing patients.Background: Smoking rates in Aboriginal Australians are gradually reducing in some age groups, but not for people in the peak reproductive years.¹ Smoking cessation is vital for cancer prevention.² Many regional programs avoid the use of threat messages when targeting Australian Aboriginal smokers.³ Aim: To assess, for the first time, the responses of Aboriginal smokers, 18–45 years, to Risk Behaviour Diagnosis scales (RBD)⁴ and intentions to quit smoking, including gender differences. Methods: We interviewed 121 Aboriginal smokers, using a structured questionnaire including adapted RBD scales. The RBD measured perceived threat (susceptibility and severity of threat) and perceived efficacy (self-efficacy and response efficacy) on Likert scales. Intentions to quit were assessed. Scales were recoded into high-low responses. Face validity was assessed via an Aboriginal panel, and scales assessed for reliability. Chi-square tests investigated the associations between intention to quit, efficacy/threat and gender. Results: Among men, intention to quit was associated with perceived efficacy (X² = 15.23;df = 1; p < 0.0001), but not with perceived threat. For women, intention to quit was neither associated with efficacy nor threat. Both genders were more likely to have high intention to quit, with high efficacy and high threat (n = 54;45%:maleX² = 12.6;df = 1; p < 0.001:femaleX²= 5.6;df = 1; p < 0.05). There was no difference in intention to quit with low efficacy-high threat for either gender (n = 39;32%). In contrast, all of the men with low threat-high efficacy (n = 5;4%) intended to quit, whereas all of the women with low threat-low efficacy (n = 6;5%) intended to quit. Conclusions: High-perceived threat was associated with high intention to quit smoking only when perceived efficacy was high. Gender differences may be a consideration. The RBD scales could be used to tailor messages to the level of efficacy and threat in clinical consultations, and in regional programs. All Aboriginal Australian smokers may benefit from increased efficacy to quit smoking.Abstract presented at the 2014 World Cancer Congress, 3-6 December 2014, Melbourne, Australia