Prostate CancerFLAME-PCNCT07282808
Focal or Radical Therapy: a Lesion-based Molecular Evaluation in Prostate Cancer
A study testing Molecular Evaluation for Risk of Recurrence after FT in people with Prostate Cancer, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Focal therapy (FT) is a new approach to treating localized prostate cancer. Instead of treating the entire prostate, it targets only the cancerous areas while preserving healthy tissue. This helps reduce side effects like urinary, sexual, and bowel problems. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Molecular Evaluation for Risk of Recurrence after FT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2026to Sep 2048
- Phase
- Interventional
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate Adenocarcinoma
- Grade Group 2-4
- MRI lesion size ≤3ml for single lesions ≤1.5ml for 2 lesions
- no gross EPE
- assessed to be completely ablatable with margin with focal therapy.
Who cannot join
- Grade Group 5 cancer
- gross EPE
- multifocal (>2) clinically significant prostate cancer
- unablatable location (very apical, basal tumors, or otherwise determined by procedurist).
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
Kae Jack Tay, MBBS, +6563214639, tay.kae.jack@singhealth.com.sg
About this study
Focal therapy (FT) is a new approach to treating localized prostate cancer. Instead of treating the entire prostate, it targets only the cancerous areas while preserving healthy tissue. This helps reduce side effects like urinary, sexual, and bowel problems.
In a prospective observational expansion of a phase II clinical trial (ProAMFocal), 80% of patients with small, localized prostate cancers treated with FT had no cancer recurrence at one year, and 70% at 3 years after treatment. The investigators studied the genetic makeup of each cancer, and found that certain genetic markers and cancer subtypes were better at predicting recurrence than standard clinical measures.
Read more
Based on this, the investigators are launching the FLAME-PC trial. In this study, all patients who qualify for FT will first undergo genetic profiling of their cancer. Patients with favorable profiles (low risk based on genetic markers) will receive FT, while those with high-risk profiles will be advised to undergo standard treatments like prostate removal or radiation.
The investigators current main goal is to test if genetic profiling can help us better select patients for FT. They believe that patients chosen using this method will have low recurrence rates (<10%) compared to those in their previous study (20-30%). FLAME-PC aims to show that personalized treatment based on genetic profiling can improve outcomes for prostate cancer patients, offering effective cancer control with fewer side effects.
Read the detailed description
Prostate cancer is the leading male cancer in the developed world. However, most prostate cancers are indolent, with only a few being aggressive, or clinically significant (csPCa). Standard radical whole-prostate treatments are effective but result in significant urinary, sexual and bowel side effects. Focal Therapy (FT) is a novel strategy where just the area of csPCa is treated, leaving normal prostate tissue intact, reducing damage to surrounding structures, thus minimizing the morbidity of treatment. This strategy is feasible if the csPCa is early and limited to a lesion of small volume.
However, despite detailed imaging and histological sampling, a significant proportion of patients identified today for FT still experience cancer recurrence. The investigators have recorded a 19.1% csPCa recurrence rate 1 year, and 29.3% (cumulative) 3 years after FT in their NMRC-NIG-funded clinical trial (n=80) despite mapping out csPCa tumors in detail using high resolution (3 Tesla) multiparametric magnetic resonance imaging (mpMRI) and extensive biopsies. Interrogating these failures in their NMRC-TA project, they found that csPCa lesions that recurred had greater transcriptomic risk (genomic classifier [GC] score 0.60 vs 0.38, P=0.014), and were more likely to be of a luminal molecular subtype (prostate subtyping classifier luminal proliferative [PSC-LP]). The investigators hypothesize that patients with lesions that are high GC, and are PSC-LP should undergo standard radical therapy rather than FT.
FLAME-PC (Focal therapy or radical therapy: Lesion-based Molecular Evaluation in Prostate Cancer), aims to prospectively validate the stratification of csPCa patients to FT or radical therapy based on their genomic risk and molecular profiles. Patients deemed clinically suitable for FT based on imaging and biopsy, will be offered FT if they additionally have a GC score ≤0.5 or non-PSC-LP subtype, whereas those with a GC score >0.5 and PSC-LP subtype will be offered radical therapy instead.
The investigators Hypothesis is that patients stratified to receive FT in FLAME-PC based on their molecular profiles will have a better cancer outcome than a historical prospective cohort of patients undergoing FT based on clinical criteria only. If proven, this will be transformative as this will be the first evidence for the use of molecular profiling in prostate cancer treatment selection. Additionally, the investigators will gain further insights into the pre-FT molecular profiling (RNA analysis will be supported by and performed in collaboration with industry partner Veracyte, Inc.)
FLAME-PC is the first prospective trial to attempt to stratify early prostate cancer treatment between FT and radical therapy. This will provide the investigators with the opportunity to transform clinical paradigm of primary treatment selection in localized prostate cancer, lead to better patient cancer outcomes with FT, and reduce overall morbidity in patients suffering from prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Molecular Evaluation for Risk of Recurrence after FT
- Keywords
- focal therapy, decipher, cryotherapy, irreversible electroporation, hifu, biomarker
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular Evaluation for Risk of Recurrence after FTDiagnostic test
Also called Decipher GC score, Transcriptomic Signature
Low Risk - Decipher GC <0.5, OR GC 0.5-0.85 and non-PSC-LP subtype High Risk - Decipher GC 0.5-0.85 and PSC-LP subtype, OR GC>0.85
| Study group | Role | What they receive |
|---|---|---|
| Focal Therapy, Low Transcriptomic Risk Cohort | Experimental | Low Transcriptomic Risk for recurrence after FT: Decipher GC Score <0.5; OR GC 0.5-0.85 and non PSC-LP subtype Receives: Diagnostic Test: Molecular Evaluation for Risk of Recurrence after FT |
| Radical Therapy, High Transcriptomic Risk Cohort | Experimental | High Transcriptomic Risk for recurrence after FT: Decipher GC 0.5-0.85 and PSC-LP subtype, or GC >0.85 Receives: Diagnostic Test: Molecular Evaluation for Risk of Recurrence after FT |
| Focal Therapy, Unselected for Transcriptomic Risk of Recurrence (Historical) | No intervention | From ProAMFocal (NCT06491056): Focal Therapy performed on all comers (no molecular evaluation) based on clinical criteria only (PSA ≤15 ng/ml, GG2-4, MRI lesion size ≤3ml for single and ≤1.5ml for two lesions, no gross EPE, determined to be completely ablatable). |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Post-Focal Therapy (FT) clinically significant cancer recurrence
Recurrence of clinically significant prostate cancer infield or outfield at 12-month MRI and biopsy after focal therapy
Measured: 12 months after FT
Secondary outcomes (6)
1 year Post-Focal Therapy Infield clinically significant cancer recurrence
Recurrence of clinically significant cancer (≥GG2) within the treated area at 12 months MRI and biopsy
Measured: 12 months after FT
1 year Post-Focal Therapy Outfield clinically significant cancer recurrence
Recurrence of clinically significant cancer (≥GG2) outside the treated area at 12 months MRI and biopsy
Measured: 12 months after FT
Failure-free survival
salvage treatment, metastatic cancer, systemic treatment, or transition to watchful waiting.
Measured: Over 20 years following enrolment
Metastatic Cancer Free Survival
Free from metastatic cancer on imaging, and/or PSA ≥50 ng/ml
Measured: Over 20 years following enrolment
Cancer-specific Survival
Death from Prostate Cancer
Measured: Over 20 years following enrolment
Overall Survival
Death from any cause
Measured: Over 20 years following enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2048 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Veracyte, Inc.
- Responsible party
- Sponsor
- Investigators
- Kae Jack Tay, MBBS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282808
- Sponsor's protocol ID
- 2025-1018
- Acronym
- FLAME-PC
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD is available to bona fide investigators who wish to collaborate
Publications
Tay KJ, Hong BH, Ong EHW, Tan KM, Pacho GC, Wong SJ, Tan YG, Law YM, Ngo NT, Tan PH, Yuen JSP, Ho HSS, Chen K, Peng J, Foo CWT, Sam XX, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Polascik TJ, Liu Y, Proudfoot J, Davicioni E, Khor LY, Chua MLK. Transcriptomic predictors of prostate cancer recurrence following focal cryotherapy: a pooled analysis of phase II trial and prospective cohort data. J Natl Cancer Cent. 2025 May 29;5(5):515-523. doi: 10.1016/j.jncc.2025.04.002. eCollection 2025 Oct.
PubMed 41111925
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focal or Radical Therapy: a Lesion-based Molecular Evaluation in Prostate Cancer
- ClinicalTrials.gov ID
- NCT07282808
- Acronym / sponsor ID
- FLAME-PC / 2025-1018
- Conditions
- Prostate Cancer
- Keywords
- focal therapy, decipher, cryotherapy, irreversible electroporation, hifu, biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Veracyte, Inc.
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2048 (estimated)
- First posted
- 15 Dec 2025 (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.
Focal therapy (FT) is a new approach to treating localized prostate cancer. Instead of treating the entire prostate, it targets only the cancerous areas while preserving healthy tissue. This helps reduce side effects like urinary, sexual, and bowel problems.
In a prospective observational expansion of a phase II clinical trial (ProAMFocal), 80% of patients with small, localized prostate cancers treated with FT had no cancer recurrence at one year, and 70% at 3 years after treatment. The investigators studied the genetic makeup of each cancer, and found that certain genetic markers and cancer subtypes were better at predicting recurrence than standard clinical measures.
Based on this, the investigators are launching the FLAME-PC trial. In this study, all patients who qualify for FT will first undergo genetic profiling of their cancer. Patients with favorable profiles (low risk based on genetic markers) will receive FT, while those with high-risk profiles will be advised to undergo standard treatments like prostate removal or radiation.
The investigators current main goal is to test if genetic profiling can help us better select patients for FT. They believe that patients chosen using this method will have low recurrence rates (<10%) compared to those in their previous study (20-30%). FLAME-PC aims to show that personalized treatment based on genetic profiling can improve outcomes for prostate cancer patients, offering effective cancer control with fewer side effects.
Detailed description
Prostate cancer is the leading male cancer in the developed world. However, most prostate cancers are indolent, with only a few being aggressive, or clinically significant (csPCa). Standard radical whole-prostate treatments are effective but result in significant urinary, sexual and bowel side effects. Focal Therapy (FT) is a novel strategy where just the area of csPCa is treated, leaving normal prostate tissue intact, reducing damage to surrounding structures, thus minimizing the morbidity of treatment. This strategy is feasible if the csPCa is early and limited to a lesion of small volume.
However, despite detailed imaging and histological sampling, a significant proportion of patients identified today for FT still experience cancer recurrence. The investigators have recorded a 19.1% csPCa recurrence rate 1 year, and 29.3% (cumulative) 3 years after FT in their NMRC-NIG-funded clinical trial (n=80) despite mapping out csPCa tumors in detail using high resolution (3 Tesla) multiparametric magnetic resonance imaging (mpMRI) and extensive biopsies. Interrogating these failures in their NMRC-TA project, they found that csPCa lesions that recurred had greater transcriptomic risk (genomic classifier [GC] score 0.60 vs 0.38, P=0.014), and were more likely to be of a luminal molecular subtype (prostate subtyping classifier luminal proliferative [PSC-LP]). The investigators hypothesize that patients with lesions that are high GC, and are PSC-LP should undergo standard radical therapy rather than FT.
FLAME-PC (Focal therapy or radical therapy: Lesion-based Molecular Evaluation in Prostate Cancer), aims to prospectively validate the stratification of csPCa patients to FT or radical therapy based on their genomic risk and molecular profiles. Patients deemed clinically suitable for FT based on imaging and biopsy, will be offered FT if they additionally have a GC score ≤0.5 or non-PSC-LP subtype, whereas those with a GC score >0.5 and PSC-LP subtype will be offered radical therapy instead.
The investigators Hypothesis is that patients stratified to receive FT in FLAME-PC based on their molecular profiles will have a better cancer outcome than a historical prospective cohort of patients undergoing FT based on clinical criteria only. If proven, this will be transformative as this will be the first evidence for the use of molecular profiling in prostate cancer treatment selection. Additionally, the investigators will gain further insights into the pre-FT molecular profiling (RNA analysis will be supported by and performed in collaboration with industry partner Veracyte, Inc.)
FLAME-PC is the first prospective trial to attempt to stratify early prostate cancer treatment between FT and radical therapy. This will provide the investigators with the opportunity to transform clinical paradigm of primary treatment selection in localized prostate cancer, lead to better patient cancer outcomes with FT, and reduce overall morbidity in patients suffering from prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focal Therapy, Low Transcriptomic Risk Cohort | Experimental | Diagnostic Test: Molecular Evaluation for Risk of Recurrence after FTLow Transcriptomic Risk for recurrence after FT: Decipher GC Score <0.5; OR GC 0.5-0.85 and non PSC-LP subtype |
| Radical Therapy, High Transcriptomic Risk Cohort | Experimental | Diagnostic Test: Molecular Evaluation for Risk of Recurrence after FTHigh Transcriptomic Risk for recurrence after FT: Decipher GC 0.5-0.85 and PSC-LP subtype, or GC >0.85 |
| Focal Therapy, Unselected for Transcriptomic Risk of Recurrence (Historical) | No intervention | –From ProAMFocal (NCT06491056): Focal Therapy performed on all comers (no molecular evaluation) based on clinical criteria only (PSA ≤15 ng/ml, GG2-4, MRI lesion size ≤3ml for single and ≤1.5ml for two lesions, no gross EPE, determined to be completely ablatable). |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prostate Adenocarcinoma
- Grade Group 2-4
- MRI lesion size ≤3ml for single lesions ≤1.5ml for 2 lesions
- no gross EPE
- assessed to be completely ablatable with margin with focal therapy.
Key exclusion criteria (4 listed)
- Grade Group 5 cancer
- gross EPE
- multifocal (>2) clinically significant prostate cancer
- unablatable location (very apical, basal tumors, or otherwise determined by procedurist).
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 |
|---|---|---|
| Molecular Evaluation for Risk of Recurrence after FTAlso: Decipher GC score, Transcriptomic SignatureLow Risk - Decipher GC <0.5, OR GC 0.5-0.85 and non-PSC-LP subtype High Risk - Decipher GC 0.5-0.85 and PSC-LP subtype, OR GC>0.85 | Diagnostic test | Focal Therapy, Low Transcriptomic Risk Cohort, Radical Therapy, High Transcriptomic Risk Cohort |
Primary outcome
1-year Post-Focal Therapy (FT) clinically significant cancer recurrence
Time frame: 12 months after FT
Recurrence of clinically significant prostate cancer infield or outfield at 12-month MRI and biopsy after focal therapy
6 secondary outcomes
1 year Post-Focal Therapy Infield clinically significant cancer recurrence
Time frame: 12 months after FT
1 year Post-Focal Therapy Outfield clinically significant cancer recurrence
Time frame: 12 months after FT
Failure-free survival
Time frame: Over 20 years following enrolment
Metastatic Cancer Free Survival
Time frame: Over 20 years following enrolment
Cancer-specific Survival
Time frame: Over 20 years following enrolment
Overall Survival
Time frame: Over 20 years following enrolment
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 Jan 2026.
- Background: PubMed 41111925Tay KJ, Hong BH, Ong EHW, Tan KM, Pacho GC, Wong SJ, Tan YG, Law YM, Ngo NT, Tan PH, Yuen JSP, Ho HSS, Chen K, Peng J, Foo CWT, Sam XX, Tuan JKL, Kanesvaran R, Gupta RT, Rozen S, Polascik TJ, Liu Y, Proudfoot J, Davicioni E, Khor LY, Chua MLK. Transcriptomic predictors of prostate cancer recurrence following focal cryotherapy: a pooled analysis of phase II trial and prospective cohort data. J Natl Cancer Cent. 2025 May 29;5(5):515-523. doi: 10.1016/j.jncc.2025.04.002. eCollection 2025 Oct.
- Individual participant dataSharing planned: Yes. Anonymized IPD is available to bona fide investigators who wish to collaborate
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RecruitingPhase 2
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RecruitingPhase 3
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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.
Kae Jack Tay, MBBS principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular Evaluation for Risk of Recurrence after FT in people with 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 5 inclusion and 4 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 Jan 2026. 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 (+65 63214639, 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?
1-year Post-Focal Therapy (FT) clinically significant cancer recurrence (time frame: 12 months after FT). 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 NCT07282808, 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 8 Jan 2026.