NCT06491056

Brief Summary

This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
267mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2023May 2048

Study Start

First participant enrolled

May 6, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2028

Expected
20 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2048

Last Updated

July 8, 2024

Status Verified

June 1, 2024

Enrollment Period

5 years

First QC Date

July 3, 2023

Last Update Submit

July 5, 2024

Conditions

Prostate Cancer

Keywords

focal therapycryotherapyhigh intensity focused ultrasoundirreversible electroporationfocal laser ablationMicrowave ablation

Outcome Measures

Primary Outcomes (10)

  • Overall Survival

    Living at 20 years after treatment

    20 years

  • Metastasis-Free Survival

    Metastasis Free at 20 years after treatment

    20 years

  • Progression-Free Survival

    Progression-Free (Local or Systemic) at 20 years after treatment

    20 years

  • Short-term Clinically Significant Prostate Cancer Recurrence

    12-18 month infield and outfield recurrence rate

    18 months

  • Intermediate-term Clinically Significant Prostate Cancer Recurrence

    5 year infield and outfield recurrence rate

    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

    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

    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

    12 months

  • Radical Intervention-free Survival

    Free of Radical Prostatectomy or Radiation at 5 years

    5 years

  • Treatment Failure-free Survival

    Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years

    5 years

Secondary Outcomes (4)

  • Intervention-Free Survival

    20 years

  • Radical Intervention-Free Survival

    20 years

  • Failure-Free Survival

    10 years

  • Failure-Free Survival

    20 years

Other Outcomes (7)

  • Inter-modality Comparison of short-term Oncological Outcomes

    12 months

  • Inter-modality Comparison of Conversion to Radical Treatment Rates

    10 years

  • Inter-modality Comparison of Treatment Failure Rates

    10 years

  • +4 more other outcomes

Study Arms (1)

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.

Device: Focal Therapy for Prostate Cancer

Interventions

Focal Therapy for Prostate CancerDEVICE

Ablation of \<75% of the prostate gland for limited volume prostate cancer

Also known as: Cryotherapy, High Intensity Focused Ultrasound (HIFU), Irreversible Electroporation (IRE), Nanoknife, HIFU, Cryoablation, Laser, Microwave ablation
Focal Therapy for Prostate Cancer

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with limited volume prostate cancer undergoing focal therapy (FT).

You may qualify if:

  • 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

You may not qualify if:

  • Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

Related Publications (4)

  • 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.

    PMID: 36083229BACKGROUND

  • Tay 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.

    PMID: 28349978BACKGROUND

  • Tan 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.

    PMID: 36895163RESULT

  • Tay 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.

    PMID: 28654336RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-Fixed Paraffin-Embedded (FFPE) Biopsy specimens of each cancerous lesion identified within the prostate.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

CryotherapyElectroporationCryosurgeryLasers

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCytological TechniquesClinical Laboratory TechniquesInvestigative TechniquesElectrochemical TechniquesAblation TechniquesSurgical Procedures, OperativeOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Kae Jack Tay, MBBS

CONTACT

63214693tay.kae.jack@singhealth.com.sg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 8, 2024

Study Start

May 6, 2023

Primary Completion (Estimated)

May 6, 2028

Study Completion (Estimated)

May 6, 2048

Last Updated

July 8, 2024

Record last verified: 2024-06

Locations

SG(1)