Robotic Surgery After Focal Ablation Therapy

Prostate Cancer Clinical Trial

— RAFT  

Official title:

Robotic Surgery After Focal Ablation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011606
• Other study ID #: 9211QM
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: October 21, 2019

Study information

• Verified date: January 2020
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The toxicity of traditional prostate cancer therapies including radical surgery and external beam radiation is well known. This has prompted a move towards focal therapy where only the cancerous part of the prostate is treated.

To date, studies have demonstrated very promising outcomes following focal therapy with the majority of men maintaining their urinary and sexual function after therapy.

In a small proportion of men, disease recurs after focal therapy. The optimal treatment for men with recurrent disease after focal therapy is yet to be defined. Patients may undergo further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU) or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate is removed.

To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after focal therapy has not been formally studied.

Traditionally, the side effects of surgery and radiation therapy performed in patients that have already undergone previous prostate cancer treatment have been considerable with high rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a significant area of the prostate untreated, the investigators believe surgery after focal prostate therapy will be associated with a much lower incidence of urinary and sexual dysfunction.

The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in men that have undergone prior focal ablation therapy. In addition, the investigators wish to perform a number of basic science studies to attempt to better understand why the patient has experienced recurrent prostate cancer after focal therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Willingness to provide informed consent

2. Males aged 18 years and over

3. Histological confirmed recurrent/residual adenocarcinoma of the prostate with Gleason score following primary focal prostate cancer ablation therapy. Biopsy must have been performed within 6 months of screening for the study

4. Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU), Cryotherapy, brachytherapy, electroporation or Photodynamic therapy

5. Serum Prostate Specific Antigen (PSA) must be below 20

6. Absence of metastatic disease

7. Life expectancy = 10 years

8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

9. MRI imaging to suggest urinary sphincter has not been incorporated in prior ablation therapy

Exclusion Criteria:

1. Serious co-existing medical illness such as chronic active autoimmune disease (within the last 6 months).

2. Other active malignancy over the last 5 years that has required systemic therapy excluding:

1. Adjuvant therapy in the curative setting

2. Non-melanoma skin cancer

3. superficial transitional cell carcinoma

3. No willingness to comply with the procedural requirements of this protocol

4. Coagulopathy/ Cirrhosis

5. Severe obesity defined as a BMI greater than 45

6. Inability to tolerate general anaesthesia

7. Prior pelvic fracture

8. Extensive tethering of the rectum caused by prior ablation therapy

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Robotic Surgery
Robotic Surgery after Focal Ablation Therapy

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas' Hospital, London	London
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)		Up to 12 months following surgical procedure
Primary	Toxicity profile prior to surgery	This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed prior to surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.	Prior to surgery (at -6 to 0 weeks screening visit)
Primary	Toxicity profile following surgery	This will be quantified using the Short-form Expanded Prostate Cancer Index Composite (EPIC)-26 performed at 3-monthly intervals for 12 months following surgery. Outcome analysis will be performed for the Bowel, urinary and sexual domains of the questionnaire.	Up to 12 months following surgery
Secondary	Oncological outcome	Will be quantified using Biochemical-free survival. Biochemical recurrence after surgery will be defined according to American Urological Association (AUA) guidance e.g. a post-surgical serum Prostate Specific Antigen (PSA) >=0.2 on 2 separate occasions.	Up to 12 months following surgical procedure
Secondary	Oncological outcome	Will be quantified using need for androgen-ablation therapy. Androgen ablation therapy will include the commencement of Bicalutamide or Goserelin therapy.	Up to 12 months following surgical procedure