What ' s known on the subject? and What does the study add? Intermittent androgen deprivation therapy (ADT) involves cycling ADT, allowing hormonal recovery during off-treatment periods. This could lead to a better quality of life during off-treatment periods and could delay progression to castration resistance. Safety and feasibility of intermittent ADT have been shown but tolerability and health-related quality of life improvement have been suggested but questioned by others. Results from randomized trials, including relapsing or mixed populations, have suggested intermittent ADT to be as effective as continuous ADT.In this study of only metastatic patients, no statistical difference in either overall survival or progression-free survival was shown between intermittent and continuous ADT and suggests that intermittent might be as safe as continuous castration. It could be an option in highly responding and well-informed metastatic patients even if no clear benefi t in health-related quality of life was shown. This intermittent modality could be of interest in metastatic patients with signifi cant treatment-induced side-effects. OBJECTIVE• To compare intermittent androgen deprivation therapy (ADT) and continuous ADT after 6 months of induction of ADT in patients with metastatic prostate cancer (PCa). PATIENTS AND METHODS• This is an open-label randomized multi-centre study conducted in 58 centres in Europe.• Patients with metastatic PCa and prostate-specifi c antigen (PSA) level > 20 ng/mL at selection were randomized after 6 months of induction of ADT (leuprorelin and fl utamide) if PSA level had decreased below 4 ng/mL.• Patients received either continuous or intermittent ADT. All patients were treated until signs of disease progression under treatment or until study end with a monthly central PSA determination and follow-up visits were performed every 3 months.• The primary endpoint was overall survival. Secondary endpoints included progression-free survival, health-related quality of life (QLQ C30 questionnaire) and safety criteria. RESULTS• Of 383 selected patients, 173 had a PSA level below 4 ng/mL after 6 months of induction of ADT and were randomized. Median overall survival (52 vs 42 months, P = 0.75) and median progression-free survival (15.1 vs 20.7 months, P = 0.74) were not signifi cantly different between continuous and intermittent ADT.• Although some differences in quality of life were observed, most of the functional and symptom scales showed no signifi cant difference between the two groups.• Signifi cantly fewer treatment -emergent adverse events occurred in the intermittent group ( P = 0.042), with the incidence of headache and hot fl ushes also lower. CONCLUSIONS• This fi rst randomized trial comparing continuous with intermittent ADT in metastatic PCa suggests that intermittent ADT might be as safe as continuous ADT.• It could be an option in highly responding and well-informed patients even if no clear benefi t in health-related quality of life was shown. KEYWORDShormonal therapy , interm...

5015 Background: Based on results of animal experiments intermittent androgen blockade was suggested to delay progression of advanced prostate cancer to the hormone refractory stage. We conducted a prospective randomized study to compare intermittent with continuous androgen suppression. Methods: This was a multi-centre, randomised, two-arm study comparing treatment with goserelin + bicalutamide (intermittent, group A) vs. goserelin + bicalutamide (continuous, group B). The primary endpoint was time to clinical and/or biochemical progression of the disease despite androgen suppression. Secondary enpoints were survival time, patient’s quality of life (QoL) and toxicity. Patients eligibility criteria were: histologically confirmed adenocarcinoma of the prostate in clinical stage T1–4N1–3M0 or T1–4N0–3M1 (D1 oder D2). After an induction phase of 24 weeks with MAB, 335 patients whose PSA decreased under 4 ng/ml or = 90% from baseline were randomized. Results: About two-thirds of the patients of both the intermittent and the continuous therapy arm (65% versus 66%, ITT population) experienced a clinical and/or biochemical disease progression due to any reason during this study. The median time to disease progression was longer for patients randomised to the intermittent therapy arm (16.6 months) compared with patients randomised to the continuous therapy arm (11.5 months). This difference however was not statistically significant (log rank test, p=0.1758). The median time to death from any cause was 51.4 month in the intermittent arm compared and 53.8 months in the continuous therapy arm (p = 0.658). There were no differences in the incidence of patients with AEs or SAEs or in any other safety parameter between patients treated intermittently and patients treated continuously. Patients’ self-assessment of their overall health and of their sexual activity appeared to be favourable in the intermittent compared with the continuous therapy arm. 88% of all patients treated intermittently experienced more than 50% of the number of treatment days as treatment-free days. Conclusions: Intermittent therapy in D1 and D2 prostate cancer patients appears to be safe and feasible. Off treatment periods are > 40 % and attribute to patients quality of life. No significant financial relationships to disclose.

Water-induced thermotherapy significantly alleviates lower urinary tract symptoms of BPH, increases peak urinary flow rate and enhances patient quality of life. This novel catheter based, minimally invasive treatment is easily administered in the outpatient setting. Water-induced thermotherapy holds promise as a useful and cost-effective option for the clinical management of BPH.

Background Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary. Methods In this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety. Results A total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B. Conclusions AA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P.