Prostate CancerRAFTNCT03011606
Robotic Surgery After Focal Ablation Therapy
A study testing Robotic Surgery in people with Prostate Cancer, run by Queen Mary University of London at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Robotic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2016to 21 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to provide informed consent
- Males aged 18 years and over
- 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
- Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU), Cryotherapy, brachytherapy, electroporation or Photodynamic therapy
- Serum Prostate Specific Antigen (PSA) must be below 20
- Absence of metastatic disease
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- Life expectancy ≥ 10 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- MRI imaging to suggest urinary sphincter has not been incorporated in prior ablation therapy
Who cannot join
- 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:
- Adjuvant therapy in the curative setting
- Non-melanoma skin cancer
- superficial transitional cell carcinoma
- No willingness to comply with the procedural requirements of this protocol
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- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guys and St Thomas' Hospital, London
London
University College London Hospital
London
About this study
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.
Read more
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.
- Conditions
- Prostate Cancer
- Being tested
- Robotic Surgery
- Keywords
- prostate, ablation, focal, cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic SurgeryProcedure or surgery
Robotic Surgery after Focal Ablation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Experimental | Single arm. All Registered patients will undergo robotic surgery Receives: Procedure: Robotic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)
Measured: 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.
Measured: 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.
Measured: Up to 12 months following surgery
Secondary outcomes (2)
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.
Measured: Up to 12 months following surgical procedure
Oncological outcome
Will be quantified using need for androgen-ablation therapy. Androgen ablation therapy will include the commencement of Bicalutamide or Goserelin therapy.
Measured: Up to 12 months following surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Cathcart, Study chair, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011606
- Sponsor's protocol ID
- 9211QM
- Acronym
- RAFT
- Status last verified
- Jan 2020
- First submitted
- 28 Jul 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33891378
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Surgery After Focal Ablation Therapy
- ClinicalTrials.gov ID
- NCT03011606
- Acronym / sponsor ID
- RAFT / 9211QM
- Conditions
- Prostate Cancer
- Keywords
- prostate, ablation, focal, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | Experimental | Procedure: Robotic SurgerySingle arm. All Registered patients will undergo robotic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willingness to provide informed consent
- Males aged 18 years and over
- 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
- Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU), Cryotherapy, brachytherapy, electroporation or Photodynamic therapy
- Serum Prostate Specific Antigen (PSA) must be below 20
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic SurgeryRobotic Surgery after Focal Ablation Therapy | Procedure or surgery | Robotic surgery |
Primary outcome
Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V)
Time frame: Up to 12 months following surgical procedure
Toxicity profile prior to surgery
Time frame: Prior to surgery (at -6 to 0 weeks screening visit)
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.
Toxicity profile following surgery
Time frame: Up to 12 months 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.
2 secondary outcomes
Oncological outcome
Time frame: Up to 12 months following surgical procedure
Oncological outcome
Time frame: Up to 12 months following surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 33891378Cathcart 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Cathcart study chair
Queen Mary University London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Surgery in people with Prostate Cancer, run by Queen Mary University of London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of surgery: This will be quantified using the Clavien-Dindo classification of complications (I-V) (time frame: Up to 12 months following surgical procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.