Transrectal ultrasound-biopsy of prostate whether performed by nurse practitioner or urologist is equally reliable if adequate training is provided. Patients are happy to undergo prostate biopsy and receive information about the diagnosis from an appropriately trained prostate cancer nurse specialist.

To determine whether needle size influences a patient's perception of pain, 50 patients requiring hormonal manipulation for prostate cancer were blindfolded and randomised to receive two goserelin ('Zoladex') or two leuprorelin ('Prostap') injections, using 16-or 23-gauge needles, respectively. Median visual analogue scale pain scores for the first injections of goserelin and leuprorelin were below the level of clinical significance and were not statistically different. Mean administration time for goserelin was significantly shorter than for leuprorelin. In conclusion, there was no statistically significant difference in pain experienced on injection of goserelin and leuprorelin when patients were unaware of needle size.

Objectives To report clinical outcomes of the Hemi‐Ablative Prostate Brachytherapy (HAPpy) trial evaluating treatment‐related toxicity and effectiveness of hemi‐gland (HG) low‐dose‐rate (LDR) prostate brachytherapy as a focal approach to control unilateral localised prostate cancer. Patients and Methods Single institution phase IIS pilot study of patients treated with focal 4D Brachytherapy™ (BXTAccelyon, Burnham, Buckinghamshire, UK). The primary outcome was patient‐reported toxicity 24 months after implant. The secondary outcome was assessment of disease control. Outcomes in HG patients were compared to whole‐gland (WG) controls obtained from our prospective cohort registry by negative binomial and linear regression models. Results Pre‐treatment demography was similar between the 30 HG patients and 362 WG controls. Post‐implant dosimetry was similar for the prostate gland target volumes and significantly reduced for the urethra and bowel in HG patients relative to WG controls, but this did not translate into a difference in post‐implant mean symptom scores between the two groups. Nevertheless, the change in score from baseline indicated that the impact on pre‐treatment symptom status was less after HG implants. Only HG patients showed a return to baseline urinary scores as early as 12 months. Sexual potency was conserved in 73% and 67% of HG and WG patients, respectively (P = 0.84). Post‐implant prostate‐specific antigen (PSA) kinetics revealed that baseline PSA was reduced at 24 months by 78% and 88% in HG and WG patients, respectively (P < 0.05). Treatment relapse occurred in one (3%) HG patient 55 months after implant and in nine (3%) WG patients at 32–67 months after implant. Conclusion This pilot study suggests that treatment‐related toxicity and biochemical outcomes after HG implants are broadly similar to those observed with WG treatment despite the lower dose delivered by HG implants.

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To assess the long-term treatment efficacy of low-dose-rate (LDR) brachytherapy for the treatment of localized prostate cancer. Patients and MethodsCause-of-death annotation in our prospective database was supplemented with death certificate information obtained via an internal audit of patients treated from 1999 to 2017 with LDR prostate brachytherapy as monotherapy or as combination with androgen deprivation therapy and/or external beam radiotherapy. Overall and disease-specific survival were the primary outcomes, estimated with Kaplan-Meier and competing risks multi-state models. Clinical variables influencing mortality were assessed with Cox proportional hazards regression in a sub-analysis of men to assess the predictive value of prostate-specific antigen (PSA) level at 48 months post implant. ResultsThe audit process began in October 2017 and culminated in June 2020 with a curated series of 2936 patients. All-cause and prostate cancer-specific death prevalence were 11% and 2.9%, respectively. The median (range) follow-up time was 10 (3-21) years and the median (range) time to death from any cause was 9 (3-21) years. At 15 years post implant the overall and prostate cancer-specific survival probability were 81% and 95%, respectively. The 15-year cumulative incidence rates of death not due and due to prostate cancer were 14% and 5%, respectively. A greater risk of death due to prostate cancer was conferred by increasing age at therapy (hazard ratio [HR] 1.1, P < 0.001), advanced clinical stages relative to T1a-T2a (HR 1.9, P = 0.048 for T2b; HR 2.7, P = 0.023 for T2c-T3b) and a 48-month PSA level >1.0 ng/mL (HR 6.8, P < 0.001). ConclusionThis study constitutes the largest retrospective analyses of long-term mortality outcomes from prospectively collected prostate brachytherapy data and confirms the excellent treatment efficacy of LDR prostate brachytherapy for localized prostate cancer. T2 clinical stage subdivisions and 48-month PSA level >1.0 ng/mL appear to be strong indicators of prostate cancer-related survival.

To report clinical and functional outcomes for patients who have undergone salvage robot-assisted seminal vesicle excision (RA-SVE) for the focal treatment of isolated seminal vesical (SV) recurrence after treatment for prostate cancer by lowdose-rate brachytherapy. Patients and MethodsPatients with rising prostate-specific antigen (PSA) after low-dose-rate prostate brachytherapy (LDR-PB) underwent multiparametric magnetic resonance imaging (mp-MRI) of the prostate and 11 C-Choline or 68 Ga-prostate-specific membrane antigen ( 68 Ga-PSMA) positron emission tomography/computed tomography (PET/CT) scan, followed by targeted transperineal biopsy of the prostate and SVs. Isolated SV recurrence were identified in 17 (0.38%) LDR-PB patients. These 17 patients were offered RA-SVE. ResultsThe median total operative time was 90 min and blood loss 50 mL with no postoperative transfusions required. The median hospital stay was 1 day. No intra-or postoperative complications were documented. Continence status was unaffected, no patient required urinary pads. Postoperative pathology confirmed SV invasion in all specimens. Surgical margins were positive in seven (41%) patients. All patients had at least one positive imaging study, although three (18%) mp-MRI and five (29%) PET/CT assessments were negative. One (6%) pre-SVE biopsy was also negative but with positive imaging. Salvage SVE failure, defined as three consecutive PSA rises or the need for further treatment, occurred in six patients of whom three had a positive margin. Overall failure-free survival rates were 86%, 67%, and 53% at 1, 2, and 3 years after SVE, respectively. ConclusionsSalvage RA-SVE appears to be a safe focal treatment, with very low morbidity, for patients with localised SV recurrence after LDR-PB. It permits deferral of androgen deprivation therapy in selected patients. Bilateral SVE is mandatory. This surgical option should be considered in patients with isolated prostate cancer recurrence to the SV.

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#3116 Background: Studies suggest that only 2% to 3% of all adult cancer patients and approximately 5% of breast cancer patients enroll in clinical trials. To better understand the factors that contribute to enrollment we collected data from patients on sources that prompted them to contact us.&#x2028; Methods: From Jan 2005 to Apr 2008 we screened nearly 400 patients for 8 Phase I/II clinical trials focused on immunotherapy of breast and ovarian cancer. We queried subjects about informational sources that led them to consider our clinical studies. Patients learned about our trials from sources including: Clinicians, the Internet (advocacy group websites, search engines, government/university sites), Other patients, Family/friends, Media, Community events and Postings seeking research participants. Many patients who cited a clinician as their referral source specifically referenced a private, multi-site breast cancer clinic in Southern California with which our clinical group has formed a partnership, or consortium. To ensure that this was represented in the data and because the clinician category comprised a large percentage of the referral sources we split the category into 2 groups-one being the private practice in California (to be referred to as “consortium”) and the other being all other clinicians.&#x2028; Results: Of the 399 patients screened, 336 (84%) were considered potentially eligible for study. A total of 72 patients, or 18% of those screened have enrolled in one of our trials to date.&#x2028; Among patients screened, most learned about our trials from clinicians outside the consortium (34%), the Internet (27%), and consortium clinicians (15%). Patients most often named her2support.org (35%) and clinicaltrials.gov (23%) as their specific Internet sources. The remaining sources, family/friends, patients, media sources, community events and postings in medical facilities, were each cited by &lt;5% of patients.&#x2028; Although consortium clinicians were responsible for only 15% of referrals, 50% of their referrals enrolled in a study. Only 16% of patients referred by other clinicians and 9% referred via the Internet were enrolled. Though other clinicians and the Internet are the most common referral sources, referrals from our consortium were significantly more likely to enroll than any other source (p&lt;0.001).&#x2028; This may be due to the fact that patients referred by the consortium were more likely to meet eligibility criteria. Relative to 93% of consortium referrals, 87% of other clinician and 79% of Internet referrals were potentially eligible for trial (p&lt;0.05). Patients referred by our consortium were significantly more likely to meet study criteria relative to those referred by other sources.&#x2028; Discussion: Physician referrals often lead to higher accrual to clinical trials relative to other referral sources. Our data reveal that accrual can be further improved by forming a close collaborative relationship with a single select practice of clinicians. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 3116.