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Robotic and Open Surgery for Prostate Cancer: A Prospective, Multi-centre, Comparative Study of Functional and Oncological Outcomes

Robotic and Open Surgery for Prostate Cancer: A Prospective, Multi-centre, Comparative Study of Functional and Oncological Outcomes

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000296336
Acronym
ROSE
Enrollment
261
Registered
2017-02-24
Start date
2016-10-07
Completion date
2025-07-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will compare the effect of robotic and open surgery for prostate cancer on functional and oncological outcomes Who is this study for? You may be eligible to join this study if you are aged 18 years or above, are undergoing prostatectomy for prostate cancer at RPA or Concord Hospitals and are clinically suitable for robotic prostatectomy. Study details Participants will either have robotic assisted laparascopic surgery or conventional open surgery as determined by the treating surgeon. All participants will undergo tests to determine urinary and erectile function, biopsies to determine oncological outcomes and questionnaires to assess quality of life. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up timepoints up to 10 years.

Interventions

Robot-Assisted Laparoscopic Prostatectomy (RALP) using "da Vinci Xi" (Registered Trademark) Intuitive Surgical Surgical System (average 3-4hrs duration) by participating surgeons at RPAH.

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult men aged 18 years and over; 2. Undergoing prostatectomy for prostate cancer at RPA or Concord Hospitals; 3. Clinically suitable for robotic prostatectomy; 4. Cognitively able to give written informed consent for participation; 5. Elective procedure.

Exclusion criteria

1. The patient lacks the ability to consent for themselves; 2. Patients unwilling to undergo pre- and post-operative evaluation according to protocol; 3. Patient or tumour factors precluding robotic surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026