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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic surgery | Experimental | Single arm. All Registered patients will undergo robotic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Surgery | Procedure | Robotic Surgery after Focal Ablation Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V) | Up to 12 months following surgical procedure | |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion Criteria:
Serious co-existing medical illness such as chronic active autoimmune disease (within the last 6 months).
Other active malignancy over the last 5 years that has required systemic therapy excluding:
No willingness to comply with the procedural requirements of this protocol
Coagulopathy/ Cirrhosis
Severe obesity defined as a BMI greater than 45
Inability to tolerate general anaesthesia
Prior pelvic fracture
Extensive tethering of the rectum caused by prior ablation therapy
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| Name | Affiliation | Role |
|---|---|---|
| Paul Cathcart | Queen Mary University London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys and St Thomas' Hospital, London | London | United Kingdom | ||||
| University College London Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33891378 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| 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 |
| London |
| United Kingdom |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |