Prostate CancerProAMFocalNCT06491056
Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)
An observational study of Prostate Cancer, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Focal Therapy for Prostate Cancer
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- 6 May 2023to 6 May 2048
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with limited volume prostate cancer undergoing focal therapy (FT).
Who may be able to join
- Prostate Adenocarcinoma
- Maximum Gleason score 4+4
- Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)
- Maximum Prostate Specific Antigen (PSA) level 15 ng/dl
- Maximum clinical stage T2c
- American Society of Anesthesiologist Criteria 2 or less
Who cannot join
- Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Kae Jack Tay, MBBS, 63214693, tay.kae.jack@singhealth.com.sg
Kae Jack Tay, MBBS
About this study
Official title: Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia
Read the detailed description
Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.
- Conditions
- Prostate Cancer
- Being tested
- Focal Therapy for Prostate Cancer
- Keywords
- focal therapy, cryotherapy, high intensity focused ultrasound, irreversible electroporation, focal laser ablation, Microwave ablation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal Therapy for Prostate CancerDevice
Also called Cryotherapy, High Intensity Focused Ultrasound (HIFU), Irreversible Electroporation (IRE), Nanoknife
Ablation of <75% of the prostate gland for limited volume prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Focal Therapy for Prostate Cancer | Patients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of <75% of the prostate gland. Receives: Device: Focal Therapy for Prostate Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Living at 20 years after treatment
Measured: 20 years
Metastasis-Free Survival
Metastasis Free at 20 years after treatment
Measured: 20 years
Progression-Free Survival
Progression-Free (Local or Systemic) at 20 years after treatment
Measured: 20 years
Short-term Clinically Significant Prostate Cancer Recurrence
12-18 month infield and outfield recurrence rate
Measured: 18 months
Intermediate-term Clinically Significant Prostate Cancer Recurrence
5 year infield and outfield recurrence rate
Measured: 5 years
Sexual Function
Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months
Measured: 12 months
Urinary Function
Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Measured: 12 months
Bowel Function
Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Measured: 12 months
Radical Intervention-free Survival
Free of Radical Prostatectomy or Radiation at 5 years
Measured: 5 years
Treatment Failure-free Survival
Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years
Measured: 5 years
Secondary outcomes (4)
Intervention-Free Survival
Intervention (Focal or Whole Gland/ Radical)-free at 20 years
Measured: 20 years
Radical Intervention-Free Survival
Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years
Measured: 20 years
Failure-Free Survival
Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years
Measured: 10 years
Failure-Free Survival
Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start6 May 2023
- Primary completion6 May 2028 (estimated)
- Study completion6 May 2048 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491056
- Sponsor's protocol ID
- CIRB 2023/2055
- Acronym
- ProAMFocal
- Status last verified
- Jun 2024
- First submitted
- 3 Jul 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ong S, Chen K, Grummet J, Yaxley J, Scheltema MJ, Stricker P, Tay KJ, Lawrentschuk N. Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus? BJU Int. 2023 Jan;131(1):20-31. doi: 10.1111/bju.15883. Epub 2022 Sep 27.
PubMed 36083229Tay KJ, Scheltema MJ, Ahmed HU, Barret E, Coleman JA, Dominguez-Escrig J, Ghai S, Huang J, Jones JS, Klotz LH, Robertson CN, Sanchez-Salas R, Scionti S, Sivaraman A, de la Rosette J, Polascik TJ. Patient selection for prostate focal therapy in the era of active surveillance: an International Delphi Consensus Project. Prostate Cancer Prostatic Dis. 2017 Sep;20(3):294-299. doi: 10.1038/pcan.2017.8. Epub 2017 Mar 28.
PubMed 28349978Tan YG, Law YM, Ngo NT, Khor LY, Tan PH, Ong EHW, Yuen JSP, Ho HSS, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Chua MLK, Polascik TJ, Tay KJ. Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study. Prostate. 2023 Jun;83(8):781-791. doi: 10.1002/pros.24517. Epub 2023 Mar 9.
PubMed 36895163Tay KJ, Cheng CWS, Lau WKO, Khoo J, Thng CH, Kwek JW. Focal Therapy for Prostate Cancer with In-Bore MR-guided Focused Ultrasound: Two-Year Follow-up of a Phase I Trial-Complications and Functional Outcomes. Radiology. 2017 Nov;285(2):620-628. doi: 10.1148/radiol.2017161650. Epub 2017 Jun 26.
PubMed 28654336
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06491056
- Acronym / sponsor ID
- ProAMFocal / CIRB 2023/2055
- Conditions
- Prostate Cancer
- Keywords
- focal therapy, cryotherapy, high intensity focused ultrasound, irreversible electroporation, focal laser ablation, Microwave ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 6 May 2023 (actual)
- Primary completion
- 6 May 2028 (estimated)
- Study completion
- 6 May 2048 (estimated)
- First posted
- 8 Jul 2024 (actual)
- 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.
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia
Detailed description
Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Focal Therapy for Prostate Cancer | – | Device: Focal Therapy for Prostate CancerPatients undergoing focal therapy (various modalities) for prostate cancer as defined by partial gland ablation of <75% of the prostate gland. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with limited volume prostate cancer undergoing focal therapy (FT).
Key inclusion criteria (6 listed)
- Prostate Adenocarcinoma
- Maximum Gleason score 4+4
- Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)
- Maximum Prostate Specific Antigen (PSA) level 15 ng/dl
- Maximum clinical stage T2c
Key exclusion criteria (1 listed)
- Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted
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 |
|---|---|---|
| Focal Therapy for Prostate CancerAlso: Cryotherapy, High Intensity Focused Ultrasound (HIFU), Irreversible Electroporation (IRE), NanoknifeAblation of <75% of the prostate gland for limited volume prostate cancer | Device | Focal Therapy for Prostate Cancer |
Primary outcome
Overall Survival
Time frame: 20 years
Living at 20 years after treatment
Metastasis-Free Survival
Time frame: 20 years
Metastasis Free at 20 years after treatment
Progression-Free Survival
Time frame: 20 years
Progression-Free (Local or Systemic) at 20 years after treatment
Short-term Clinically Significant Prostate Cancer Recurrence
Time frame: 18 months
12-18 month infield and outfield recurrence rate
Intermediate-term Clinically Significant Prostate Cancer Recurrence
Time frame: 5 years
5 year infield and outfield recurrence rate
Sexual Function
Time frame: 12 months
Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months
Urinary Function
Time frame: 12 months
Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Bowel Function
Time frame: 12 months
Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Radical Intervention-free Survival
Time frame: 5 years
Free of Radical Prostatectomy or Radiation at 5 years
Treatment Failure-free Survival
Time frame: 5 years
Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years
4 secondary outcomes
Intervention-Free Survival
Time frame: 20 years
Radical Intervention-Free Survival
Time frame: 20 years
Failure-Free Survival
Time frame: 10 years
Failure-Free Survival
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 36083229Ong S, Chen K, Grummet J, Yaxley J, Scheltema MJ, Stricker P, Tay KJ, Lawrentschuk N. Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus? BJU Int. 2023 Jan;131(1):20-31. doi: 10.1111/bju.15883. Epub 2022 Sep 27.
- Background: PubMed 28349978Tay KJ, Scheltema MJ, Ahmed HU, Barret E, Coleman JA, Dominguez-Escrig J, Ghai S, Huang J, Jones JS, Klotz LH, Robertson CN, Sanchez-Salas R, Scionti S, Sivaraman A, de la Rosette J, Polascik TJ. Patient selection for prostate focal therapy in the era of active surveillance: an International Delphi Consensus Project. Prostate Cancer Prostatic Dis. 2017 Sep;20(3):294-299. doi: 10.1038/pcan.2017.8. Epub 2017 Mar 28.
- Results publication: PubMed 36895163Tan YG, Law YM, Ngo NT, Khor LY, Tan PH, Ong EHW, Yuen JSP, Ho HSS, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Chua MLK, Polascik TJ, Tay KJ. Patient-reported functional outcomes and oncological control after primary focal cryotherapy for clinically significant prostate cancer: A Phase II mandatory biopsy-monitored study. Prostate. 2023 Jun;83(8):781-791. doi: 10.1002/pros.24517. Epub 2023 Mar 9.
- Results publication: PubMed 28654336Tay KJ, Cheng CWS, Lau WKO, Khoo J, Thng CH, Kwek JW. Focal Therapy for Prostate Cancer with In-Bore MR-guided Focused Ultrasound: Two-Year Follow-up of a Phase I Trial-Complications and Functional Outcomes. Radiology. 2017 Nov;285(2):620-628. doi: 10.1148/radiol.2017161650. Epub 2017 Jun 26.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Singapore General Hospital at 1 site in Singapore.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kae Jack Tay, MBBS (63214693, tay.kae.jack@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 20 years). The study lists 10 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 NCT06491056, which also lists 4 linked publications.
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 8 Jul 2024.