Phase III postoperative adjuvant radiotherapy after radical prostatectomy compared with radical prostatectomy alone in pT3 prostate cancer with postoperative undetectable prostate-specific antigen: ARO 96-02/AUO AP 09/95. A community-based randomised controlled trial of three different educational resources for men about prostate cancer screening. Empowerment of men newly diagnosed with prostate cancer. A randomized controlled trial of shared decision making for prostate cancer screening. Does evidence-based information about screening for prostate cancer enhance consumer decision-making? A randomised controlled trial. Internet patient decision support: a randomized controlled trial comparing alternative approaches for men considering prostate cancer screening. The effect of an illustrated pamphlet decision-aid on the use of prostate cancer screening tests. The effect of dyadic intervention on self-efficacy, social support, and depression for men with prostate cancer. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer.
Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP.
                After RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival.
                Biochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%.
                Adjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival. Randomised evaluations of resources to facilitate informed decisions about prostate cancer screening are rarely conducted. In this study, 421 men recruited from the community were randomly allocated to receive a leaflet (n = 140) or one of two resources meeting criteria for a decision-aid: a video (n = 141) or an evidence-based booklet, developed by the authors (n = 140). Men in all three groups demonstrated significant increases in knowledge scores from pre to post-test. Scores were significantly higher at post-test amongst those who had received our evidence-based booklet compared with men who received the leaflet or video (P < 0.001). Scores were significantly modified by men's preferences for decisional control (P = 0.002). Decisional conflict was significantly lower amongst men receiving the evidence-based booklet (P = 0.038). Men receiving the evidence-based booklet also were less likely to accept a recommendation by a GP to undergo prostate-specific-antigen (PSA) screening (P = 0.003). Men require detailed information about the pros and cons of PSA screening in order to make an informed decision. Resources are not equivalent in achieving these outcomes. The purpose of this study was to explore the hypothesis that assisting men with prostate cancer to obtain information would enable them to assume a more active role in treatment decision making and decrease their levels of anxiety and depression. Respondents were recruited from one community urology clinic in Winnipeg, Manitoba. Sixty newly diagnosed men were randomly assigned to receive either a self-efficacy information intervention that consisted of a written information package with discussion, a list of questions they could ask their physician, and an audiotape of the medical consultation (n = 30), or a written information package alone (n = 30). Men completed measures of preferred decisional role as the pretest; anxiety and depression before the intervention, and at 6 weeks post-intervention; and assumed decisional role at 6 weeks post-intervention. Results demonstrated that men in the intervention group assumed a significantly more active role in treatment decision making, and had lower state anxiety levels at 6 weeks. Levels of depression were similar for both groups at 6 weeks. This group of older men do want to be informed and participate in medical decisions. Further efforts are required to evaluate the efficacy of such an intervention in other community urology clinics. To evaluate a patient-educational approach to shared decision making for prostate cancer screening.
                Randomized controlled trial with preoffice visit assessment and 2-week follow-up.
                University-based family practice center.
                Men aged 45 through 70 years with no history of prostate cancer or treatment for prostate disease (N = 160). Two patients were unavailable for follow-up.
                Twenty-minute educational videotape on advantages and disadvantages of prostate-specific antigen (PSA) screening for prostate cancer.
                A measure of patients' core knowledge of prostate cancer developed for this study, reported preferences for PSA testing, and ratings of the videotape.
                Patients' core knowledge at baseline was poor. At 2-week follow-up, subjects undergoing videotape intervention showed a 78% improvement in the number of knowledge questions answered correctly (P = .001), and knowledge increased about mortality due to early-stage prostate cancer, PSA screening performance, treatment-related complications, and disadvantages of screening. No overall change was observed for control subjects. At follow-up, 48 (62%) of 78 intervention patients planned to have the PSA test compared with 64 (80%) of 80 control patients (18.5% absolute reduction; 95% confidence interval, 4.6%-32.4%; P = .009). Intervention subjects rated favorably the amount of information provided and the clarity, balance, and length of the videotape and would recommend the videotape to others.
                Patient education regarding the potential benefits and harms of early detection of prostate cancer can lead to more informed decision making. Incorporating the PSA videotape into the periodic health examination for asymptomatic men aged 50 years and older is recommended. Efforts to educate men about the controversy surrounding prostate cancer screening are well intended but rarely evaluated rigorously. We evaluated an evidence-based (EB) booklet for men designed to promote informed decision-making. We also determined whether men's preference for involvement in decision-making ("passive", "collaborative" or "active") modified its impact.
                Men aged 40-70 years were recruited from the practices of 13 local general practitioners (GPs) in Sydney, Australia. They completed a self-administered questionnaire before seeing their GP, who, according to pre-randomised codes, distributed either our EB booklet or conventional information. Post-test questionnaires were mailed to men three days later. Of the 248 eligible men recruited, 214 (86% response rate) returned post-test questionnaires. Knowledge of evidence and of risk of developing and dying from prostate cancer, attitudes, interest in screening for prostate-specific antigen (PSA), worry and decisional conflict were the main outcome measures.
                Compared with those receiving conventional information, men receiving the EB booklet had significantly improved knowledge (50% of items correct, 95% CI 46-53%; vs 45% correct, 95% CI 42-48%) (p = 0.048) and lower levels of decisional conflict (mean 21.6, 95% CI 20.7-22.5; vs mean 24.3, 95% CI 23.4-25.2) (p < 0.001). Interest in PSA screening was significantly reduced in both groups at post-test (p < 0.001). Men preferring a "passive" approach to decision-making gained as much from our EB booklet as those with "active" or "collaborative" preferences.
                Our findings show the benefits of providing evidence-based information to men about PSA screening. Our EB booklet facilitated informed choice, even among "passive" decision-makers. We conducted a randomized controlled trial to evaluate the effects of patient decision support Web sites on decision quality for men considering prostate cancer screening.
                Men older than 50 years (N = 611) were randomly assigned to 1 of 4 Internet conditions: traditional didactic decision aid providing information about prostate-specific antigen (PSA) screening options and outcomes; chronic disease trajectory model for prostate cancer followed by a time-trade-off exercise; both the didactic decision aid and the chronic disease trajectory model; or links to public prostate cancer-specific Web sites from credible sources (control condition). Participants completed questionnaires at baseline and after their physical examination. Primary outcome measures were PSA test choice, prostate cancer treatment preferences, knowledge and concern about prostate cancer, and decisional conflict.
                Participants assigned to view public Web sites were less likely to review information (116 participants [76.8%] reviewed) than those assigned to experimental groups (399 [86.7%] reviewed; P = .004). Greater reductions in PSA screening from pretest to posttest were observed among participants assigned to the traditional decision aid (-9.1%) or chronic disease trajectory model (-8.7%), compared with participants assigned to the combination (-5.3%) or control (-3.3%) groups (P = .047). Preferences for watchful waiting increased significantly in all 4 groups (baseline, 219 [35.8%]; follow-up, 303 [66.2%]; P < .001). Knowledge scores were lowest for those assigned to public Web sites (mean [SD] score, 7.49 [0.19] of questions correct) and highest for the traditional decision aid (8.65 [0.18] of questions correct; P = .005).
                Public Web sites about prostate cancer provide less effective decision support than a specially designed Internet decision aid. Prostate cancer screening with serum prostate-specific antigen (PSA) and digital rectal examination (DRE) continues to increase. Our goal was to test the effect of a prostate cancer screening decision-aid on patients' knowledge, beliefs, and use of prostate cancer screening tests.
                Our study was a randomized controlled trial of a prostate cancer screening decision-aid consisting of an illustrated pamphlet as opposed to a comparison intervention. We included 257 men aged 50 to 80 years who were receiving primary care at a Department of Veterans Affairs Hospital in Milwaukee, Wisconsin. The decision-aid provided quantitative outcomes of prostate cancer screening with DRE and PSA. We subsequently evaluated prostate cancer screening knowledge, beliefs, and test use.
                The illustrated pamphlet decision-aid was effective in improving knowledge of prostate cancer screening tests: 95% of the experimental group were aware of the possibility of false-negative test results compared with 85% of the comparison group (P <.01). Ninety-one percent of the experimental group were aware of the possibility of a false-positive screening test result compared with 65% of the comparison group (P <.01). However, there was no difference in the use of prostate cancer screening between the experimental (82%) and comparison (84%) groups, (P >.05).
                When used in a primary care setting, an illustrated pamphlet decision-aid was effective in increasing knowledge of prostate cancer screening tests but did not change the use of these tests. Urinary and sexual dysfunctions are side effects of radical prostatectomy (RP) for prostate cancer (PC) that contribute to depression. Despite the effectiveness of support groups at reducing depression in cancer patients, men typically do not participate in them. The purpose of this pilot study was to test the effects of a dyadic intervention (one-to-one support) on social support (Modified Inventory of Socially Supportive Behaviors), self-efficacy (Stanford Inventory of Cancer Patient Adjustment), and depression (Geriatric Depression Scale). Subjects were randomized to group. Controls (N=15; Mage=59.7) received usual care. Experimentals were paired with long-term survivors (LTS) who had RP and who had treatment side effects in common. Experimentals (N=15; Mage=57.5) met with a LTS 8 times in 8 weeks to discuss concerns associated with survivorship. No significant differences were detected on social support, but after 4 weeks, significant differences were present on depression between controls and experimentals, however these differences were not seen at 8 weeks. After 8 weeks, there were also significant differences on self-efficacy between controls and experimentals. Weekly anecdotal data supported the feasibility and acceptance of the intervention that was a low cost strategy effective at reducing depression and increasing self-efficacy in men treated by RP. Future research directions and clinical application is presented.
                Copyright 2003 John Wiley & Sons, Ltd. To evaluate the effect of 3 months vs. 8 months of neoadjuvant hormonal therapy before conventional dose radiotherapy (RT) on disease-free survival using prostate-specific antigen PSA and biopsies as end points for clinically localized prostate cancer.
                Between February 1995 and June 2001, 378 men were randomized to either 3 or 8 months of flutamide and goserelin before conventional-dose RT (66 Gy) at four participating centers. The median patient age was 72 years (range, 50-84 years). The stage distribution was 17% T1c, 35% T2a, 34% T2b-T2c, 13% T3-T4. The Gleason score (GS) was < or =6 in 51%, 7 in 38%, and 8-10 in 11%. The median baseline PSA level was 9.7 ng/mL (range, 1.3-189 ng/mL). Of the 378 men, 26% were low risk (Stage T1c-T2a, GS < or =6, PSA <10 ng/mL), 43% were intermediate risk (Stage T2b or GS 7 or PSA 10-20 ng/mL), and 31% were high risk (Stage T3 or GS 8-10 or PSA >20 ng/mL). The two arms were balanced in terms of age, GS, T stage, risk group, and presenting PSA level. The median follow-up was 44 months (range, 10-84 months), and 361 patients were available for evaluation.
                The 8-month arm achieved a lower PSA level before starting RT (0.37 vs. 0.74 ng/mL, p < or =0.001) and had a greater downsizing of the prostate (mean volume 26.6 cm(3) vs. 30.5 cm(3), p < or =0.001). However, the actuarial freedom from failure rate (biochemical by American Society for Therapeutic Radiology and Oncology definition, local or distant) for the 3-month vs. 8-month arms at 3 years was 66% vs. 68% and by 5 years was 61% vs. 62%, respectively (p = 0.36). No statistically significant difference was noted in the types of failure between the two arms (crude final status): biochemical, 22.2% vs. 22.3%; local, 10.2% vs. 6.5%; and distant, 3.4% vs. 4.4% (p = 0.61). Two-year post-RT biopsies were done in 57% (n = 205). Negative biopsies were obtained in 68% of the 3-month and 77% of the 8-month patients; 18% and 14% had indeterminate biopsies and 14% and 9% were positive for residual cancer (p = 0.34) in the two arms, respectively. The median PSA level for nonfailing patients was 0.50 ng/mL in both the 3-months and 8-month arms. A suggestion of improvement was found in the 8-month arm for disease-free survival at 5 years for high-risk patients (39% vs. 52%) but did not achieve statistical significance.
                A longer period of neoadjuvant hormonal therapy before standard-dose RT does not appear to confer a benefit in terms of disease-free survival or to alter failure patterns. Failure was delayed in the 8-month arm, but this advantage was lost by 5 years of follow-up. A suggestion of benefit was noted with a longer period of hormonal therapy for high-risk patients.
The existing trials provide insufficient evidence to allow confident statements to be made about the relative beneficial and harmful effects of RP and WW for patients with localised prostate cancer. The results of ongoing trials should help to inform treatment decisions for men with screen-detected localised prostate cancer.