Clinical trial NCT03011606: Robotic Surgery After Focal Ablation Therapy
Official title: Robotic Surgery After Focal Ablation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate
ablation
focal
cancer
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)
timeFrame: Up to 12 months following surgical procedure
measure: Toxicity profile prior to surgery
timeFrame: Prior to surgery (at -6 to 0 weeks screening visit)
measure: Toxicity profile following surgery
timeFrame: Up to 12 months following surgery
Secondary outcomes:
measure: Oncological outcome
timeFrame: Up to 12 months following surgical procedure
measure: Oncological outcome
timeFrame: Up to 12 months following surgical procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas' Hospital, London
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: Queen Mary University London
name: Paul Cathcart
role: STUDY_CHAIR
References:
citation: Cathcart P, Ribeiro L, Moore C, Ahmed HU, Leslie T, Arya M, Orczyk C, Hindley RG, Cahill F, Prendergast A, Coetzee C, Yogeswaran Y, Tunna K, Sooriakumaran P, Emberton M. Outcomes of the RAFT trial: robotic surgery after focal therapy. BJU Int. 2021 Oct;128(4):504-510. doi: 10.1111/bju.15432. Epub 2021 May 13.