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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial
ClinicalTrials.gov ID: NCT06915909
What this study is testing
- What it's testing
- The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join if
- Patient indicated for non-emergent robotic Prostatectomy surgery
- Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study
- Males, aged 18 to 75 years
- Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or...
- Are American Society of Anaesthesiologists (ASA) Class I, II, or III);
You likely can't join if
- Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless...
- Patients requiring any surgical procedure in addition to Prostatectomy and or / Pelvic Lymph node dissection
- Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity
- Inability to provide informed consent
- Unable or unwilling to attend follow-up visits and examinations
- Uncontrolled hypertension (=/\>Systolic: 180 mmHg/Diastolic: 120 mmHg) and/or diabetes mellitus (Blood sugar level: \>200 mg/dL)
See the full eligibility criteria
- Patient indicated for non-emergent robotic Prostatectomy surgery
- Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study
- Males, aged 18 to 75 years
- Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioural recommendations and office visits
- Are American Society of Anaesthesiologists (ASA) Class I, II, or III);
- Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);
- Patients requiring any surgical procedure in addition to Prostatectomy and or / Pelvic Lymph node dissection
- Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity
- Inability to provide informed consent
- Unable or unwilling to attend follow-up visits and examinations
- Uncontrolled hypertension (=/\>Systolic: 180 mmHg/Diastolic: 120 mmHg) and/or diabetes mellitus (Blood sugar level: \>200 mg/dL)
- Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV
- History of chronic alcohol or drug abuse within 2 years of the screening visit
- Chronic renal failure or on dialysis
- Significant complicating medical history or immunocompromised
- History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma
- Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;
- Any medical condition which precludes compliance with the study
- people with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of...
- Previous or current history of being on regular analgesia / pain killers
The study team makes the final eligibility decision.
Where it's taking place
- Stevenage, Hertfordshire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stevenage, Hertfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.