Automated Bone Scan Index as an Imaging Biomarker to Predict Overall Survival in the Zometa European Study/SPCG11.

BACKGROUND: Owing to the large variation in treatment response among patients with high-risk prostate cancer, it would be of value to use objective tools to monitor the status of bone metastases during clinical trials. Automated Bone Scan Index (aBSI) based on artificial intelligence has been proposed as an imaging biomarker for the quantification of skeletal metastases from bone scintigraphy. OBJECTIVE: To investigate how an increase in aBSI during treatment may predict clinical outcome in a randomised controlled clinical trial including patients with high-risk prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively selected all patients from the Zometa European Study (ZEUS)/SPCG11 study with image data of sufficient quality to allow for aBSI assessment at baseline and at 48-mo follow-up. Data on aBSI were obtained using EXINIboneBSI software, blinded for clinical data and randomisation of zoledronic acid treatment. Data on age, overall survival (OS), and prostate-specific antigen (PSA) at baseline and upon follow-up were available from the study database. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Association between clinical parameters and aBSI increase during treatment was evaluated using Cox proportional-hazards regression models, Kaplan-Meier estimates, and log-rank test. Discrimination between prognostic variables was assessed using the concordance index (C-index). RESULTS AND LIMITATIONS: In this cohort, 176 patients with bone metastases and a change in aBSI from baseline to follow-up of ≤0.3 had a significantly longer median survival time than patients with an aBSI change of >0.3 (p<0.0001). The increase in aBSI was significantly associated with OS (p<0.01 and C-index=0.65), while age and PSA change were not. CONCLUSIONS: The aBSI used as an objective imaging biomarker predicted outcome in prostate cancer patients in the ZEUS/SPCG11 study. An analysis of the change in aBSI from baseline to 48-mo follow-up represents a valuable tool for prognostication and monitoring of prostate cancer patients with bone metastases. PATIENT SUMMARY: The increase in the burden of skeletal metastases, as measured by the automated Bone Scan Index (aBSI), during treatment was associated with overall survival in patients from the Zometa European Study/SPCG11 study. The aBSI may be a useful tool also in monitoring prostate cancer patients with newly developed bone metastases.

Report of a consensus meeting on focal low dose rate brachytherapy for prostate cancer.

What's known on the subject? and What does the study add? Whole gland brachytherapy has been used to successfully treat prostate cancer but the protocol for focal therapy has not previously been established. The consensus findings provide guidance on patient selection for focal brachytherapy as well as recommendations for conducting therapy and patient follow-up. Low dose rate prostate brachytherapy is an effective treatment for localized prostate cancer. Recently, it has been considered for use in a focused manner whereby treatment is targeted only to areas of prostate cancer. The objective of focal brachytherapy is to provide effective cancer control for low-risk disease but with reduced genitourinary and rectal side-effects in a cost-effective way. We report on the outputs of a consensus meeting of international experts in brachytherapy and focal therapy convened to consider the feasibility and potential development of focal brachytherapy. A number of factors were considered for focal brachytherapy including optimal patient selection, disease characterization and localization, treatment protocols and outcome measures. The consensus meeting also addressed the design of a clinical trial that would assess the oncological outcomes and side-effect profiles resulting from focal brachytherapy.

[Development and validation of the first Spanish questionnaire of quality of life in patients with prostate cancer, based on the patient's perception]. / Desarrollo y validación del primer cuestionario español de calidad de vida en pacientes con cáncer de próstata, basado en la percepción del paciente.

BACKGROUND: To ensure health related quality of life (HRQOL) during the survival of patients with prostate cancer (PCa) is a priority. The development of specific HRQOL questionnaires aids to assess the disease impact, its treatment and the patient's perception (concerns, expectations and interests) that might go unnoticed. OBJECTIVES: To develop and validate the first Spanish HRQL questionnaire specific for patients with PCa. MATERIALS AND METHODS: The questionnaire CAVIPRES had 3 phases of development: 1.-generation of items (literature research, expert meeting and 2 focus groups with patients), 2.- reduction of items (self-administered survey with a preliminary version and clinimetric and psychometric analyses), 3: validation of the questionnaire (observational study with 2 visits where patients completed the CAVIPRES, SF-36 and UCLA-PCI tests and analysis of psychometric properties in terms of validity, reliability and sensitivity to change). RESULTS: A preliminary list of 75 potential items was obtained in phase 1.412 patients were recruited and answered this preliminary version in phase 2. 35 items were deleted. 436 patients responded to the definitive-30-items obtained version (CAVIPRES-30) in Phase 3. CAVIPRES-30 showed feasibility (items lost <4%, ceiling effect: 0% floor effect: 0% in the overall score), high reliability in terms of internal consistency (alpha = 0.77) and re-test reliability (ICC = 0.92). There was a good correlation between tests CAVIPRES and SGF-36 and UCLA-PCI for similar domains CONCLUSION: The questionnaire CAVIPRES-30 is a feasible, reliable and sensitive to change, useful in clinical research for prostate cancer.