Clinical impact of the predict prostate risk communication tool in men newly diagnosed with non-metastatic prostate cancer: A multi-centre randomised controlled trial

ABSTRACTIntroductionPredict Prostate is a freely-available online personalised risk communication tool for men newly diagnosed with non-metastatic prostate cancer. Its accuracy has been assessed in multiple validation studies but the clinical impact of the tool on patient decision-making had not previously been evaluated.MethodsA multi-centre randomised controlled trial was performed across 8 UK centres, wherein newly diagnosed men considering either active surveillance or radical treatment, were randomised to either standard of care (SOC) information or SOC and presentation of Predict Prostate. Validated questionnaires were completed assessing impact of the tool on decisional conflict, uncertainty, anxiety and understanding of survival.Results156 patients were included; mean age 67 years (range 44-80) and PSA of 6.9ng/ml (range 0.5-59.8). 81 were randomised to the Predict Prostate arm, and 75 to SOC information only. Mean decisional conflict scores were 26% lower in the Predict Prostate group (mean = 15.9) than in the SOC group (mean = 21.5) (p=0.01). Scores on the ‘effective decision’, ‘uncertainty’ and ‘value clarity’ subscales all indicated that the Predict Prostate group felt more informed and clear about their decision (all p<0.05). There was no significant difference in anxiety between the two groups.Patient perceptions of 15-year prostate cancer specific mortality (PCSM) and overall survival benefit from radical treatment were considerably lower among men in the Predict Prostate group (p<0.0001). 58% of men reported the Predict Prostate estimates for PCSM were lower than expected, and 35% reported being less likely to select radical treatment. Over 90% of patients in the Predict Prostate group found it useful and 94% would recommend it to others.ConclusionPredict Prostate reduces decisional conflict and uncertainty in non-metastatic prostate cancer and shifts patient perceptions around prognosis to be more realistic. This is the first randomised study of such a tool in this context; it demonstrates Predict Prostate can directly inform the complex decision-making process in prostate cancer.

Download Full-text

Additional Treatments to the Local tumour for metastatic prostate cancer-Assessment of Novel Treatment Algorithms (IP2-ATLANTA): protocol for a multicentre, phase II randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042953 ◽

2021 ◽

Vol 11 (2) ◽

pp. e042953

Author(s):

Martin John Connor ◽

Taimur Tariq Shah ◽

Katarzyna Smigielska ◽

Emily Day ◽

Johanna Sukumar ◽

...

Keyword(s):

Prostate Cancer ◽

Lymph Node ◽

Androgen Receptor ◽

Randomised Controlled Trial ◽

Phase Ii ◽

Metastatic Prostate Cancer ◽

Controlled Trial ◽

Pelvic Lymph Node ◽

Study Results ◽

Randomised Controlled

IntroductionSurvival in men diagnosed with de novo synchronous metastatic prostate cancer has increased following the use of upfront systemic treatment, using chemotherapy and other novel androgen receptor targeted agents, in addition to standard androgen deprivation therapy (ADT). Local cytoreductive and metastasis-directed interventions are hypothesised to confer additional survival benefit. In this setting, IP2-ATLANTA will explore progression-free survival (PFS) outcomes with the addition of sequential multimodal local and metastasis-directed treatments compared with standard care alone.MethodsA phase II, prospective, multicentre, three-arm randomised controlled trial incorporating an embedded feasibility pilot. All men with new histologically diagnosed, hormone-sensitive, metastatic prostate cancer, within 4 months of commencing ADT and of performance status 0 to 2 are eligible. Patients will be randomised to Control (standard of care (SOC)) OR Intervention 1 (minimally invasive ablative therapy to prostate±pelvic lymph node dissection (PLND)) OR Intervention 2 (cytoreductive radical prostatectomy±PLND OR prostate radiotherapy±pelvic lymph node radiotherapy (PLNRT)). Metastatic burden will be prespecified using the Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease (CHAARTED) definition. Men with low burden disease in intervention arms are eligible for metastasis-directed therapy, in the form of stereotactic ablative body radiotherapy (SABR) or surgery. Standard systemic therapy will be administered in all arms with ADT±upfront systemic chemotherapy or androgen receptor agents. Patients will be followed-up for a minimum of 2 years. Primary outcome: PFS. Secondary outcomes include predictive factors for PFS and overall survival; urinary, sexual and rectal side effects. Embedded feasibility sample size is 80, with 918 patients required in the main phase II component. Study recruitment commenced in April 2019, with planned follow-up completed by April 2024.Ethics and disseminationApproved by the Health Research Authority (HRA) Research Ethics Committee Wales-5 (19/WA0005). Study results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03763253; ISCRTN58401737

Download Full-text

STAMPEDE: Systemic Therapy for Advancing or Metastatic Prostate Cancer — A Multi-Arm Multi-Stage Randomised Controlled Trial

Clinical Oncology ◽

10.1016/j.clon.2008.07.002 ◽

2008 ◽

Vol 20 (8) ◽

pp. 577-581 ◽

Cited By ~ 27

Author(s):

N.D. James ◽

M.R. Sydes ◽

N.W. Clarke ◽

M.D. Mason ◽

D.P. Dearnaley ◽

...

Keyword(s):

Prostate Cancer ◽

Randomised Controlled Trial ◽

Systemic Therapy ◽

Metastatic Prostate Cancer ◽

Controlled Trial ◽

Multi Stage ◽

Randomised Controlled

Download Full-text

Danish Evaluation of Your Heart Forecast (DANY) - Study Protocol for a Randomised Controlled Trial on an Interactive Risk-communication Tool aimed at improving High Blood Pressure Patients’ adherence.

10.21203/rs.2.13844/v1 ◽

2019 ◽

Author(s):

Anders Elkær Jensen ◽

Jens Søndergaard ◽

Niels Kristian Kjær ◽

Rod Jackson ◽

Jesper Bo Nielsen

Keyword(s):

Risk Factors ◽

Blood Pressure ◽

Health Literacy ◽

Randomised Controlled Trial ◽

Risk Communication ◽

Controlled Trial ◽

Pressure Control ◽

Communication Tool ◽

Hypertensive Patients ◽

Randomised Controlled

Abstract Background To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Communicating risk of cardio-vascular-disease is a complex and individualised task, since the risk itself is a combination of multiple personal risk factors. Raised blood pressure is but one of these risk factors. In Denmark, one third of hypertensive patients are adequately treated, with regards to national guidelines. One reason for this meagre status is low treatment adherence, and tools with documented effects for increasing patient adherence are limited. Our objective is to evaluate the effect of a personalised, interactive and dynamic risk-assessment and risk-communication tool: “Your Heart Forecast” on blood pressure control, primary non-compliance, health literacy and patient empowerment.Methods Cluster-randomised controlled trial in general practice. Effect measures are adherence, blood pressure, lipid levels and empowerment at inclusion and after 6 and 12 months. To identify other benefits or possible adverse effects of the intervention, qualitative interviews will be conducted with a subgroup of patients. Discussion The investigators will explore effects of Your Heart Forecast on patients’ health literacy, adherence, empowerment and blood pressure control. The DANish evaluation of Your heart forecast (DANY) project will be the first to rigorously evaluate effects of YHF in Denmark and to link adherence of hypertensive patients exposed to Your Heart Forecast with the national databases of prescriptions and health services provided.

Download Full-text