High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)

Comprehensive Cancer Centre The Netherlands

Status: Enrolling

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05931419

2022-13682

Details and patient eligibility

About

Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy combined with androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.

Full description

Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) combined with Androgen Deprivation Therapy (ADT) are widely used treatment modalities for high-risk non-metastatic prostate cancer (HR-PCa). Both treatments are associated with adverse effects and can have a great impact on health-related quality of life (HRQoL). To date there is no consensus on which of both is the optimal treatment for men with HR-PCa, as it is unclear which treatment is superior in terms of HRQoL, cost-effectiveness, progression-free survival (PFS) and distant metastases-free survival (DMFS). This is reflected in substantial variation between individual hospitals in the utilization of both treatment options that is not explained by patient- and tumor characteristics or patient preferences. In the RECOVER study we aim to address this knowledge gap. The insights gained can be used to tailor recommendations in (national) guidelines and in shared decision-making tools. This allows healthcare professionals to better inform their patients and allows patients to make well-informed choices.

Enrollment: 837 estimated patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed de novo non-metastatic high-risk prostate cancer.
• cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
• International Society of Urological Pathology (ISUP) grade ≥4 and/or
• Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
• Fit for treatment with either RARP or EBRT and ADT (WHO performance status 0-1)
• Living in the Netherlands
• Able to read and understand the Dutch language

Exclusion criteria

• Histological types other than adenocarcinoma
• Diagnosis and/or treatment in a hospital abroad
• Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan

Trial design

837 participants in 2 patient groups

Robot assisted radical prostatectomy (RARP)

Description:

Robot-assisted radical prostatectomy, potentially as part of multimodality therapy with adjuvant radiotherapy or with (neo)adjuvant androgen deprivation therapy. Pelvic lymph node dissection (PLND) may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and may be followed by adjuvant treatment such as lymph node irradiation.

External beam radiotherapy (EBRT) combined with androgen deprivation therapy (ADT)

Description:

External beam radiotherapy (hypofractionated or conventionally fractionated) at a biologically effective dose converted to 2Gy fractions (α/β:1.5) of at least 76Gy. EBRT may be combined with a brachytherapy boost and PLND may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and lymph node irradiation may be performed. Patients should receive ADT for at least 6 months.