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Recruiting

NCT Number: NCT06491056

Prospective Asian Multicenter Prostate Cancer Focal Therapy Study (ProAMFocal)

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

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Singapore General Hospital

Singapore, 169856

Location status: Recruiting

Location contact

Kae Jack Tay, MBBS

CONTACT

[email protected]

63214693

Kae Jack Tay, MBBS

PRINCIPAL_INVESTIGATOR

About this study

Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Focal Therapy for Prostate Cancer

Device

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

Other names: Cryotherapy, High Intensity Focused Ultrasound (HIFU), Irreversible Electroporation (IRE), Nanoknife, HIFU, Cryoablation, Laser, Microwave ablation

Primary outcomes

  1. Overall Survival

    Time frame: 20 years

    Living at 20 years after treatment

  2. Metastasis-Free Survival

    Time frame: 20 years

    Metastasis Free at 20 years after treatment

  3. Progression-Free Survival

    Time frame: 20 years

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

  4. Short-term Clinically Significant Prostate Cancer Recurrence

    Time frame: 18 months

    12-18 month infield and outfield recurrence rate

  5. Intermediate-term Clinically Significant Prostate Cancer Recurrence

    Time frame: 5 years

    5 year infield and outfield recurrence rate

  6. 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

  7. 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

  8. 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

  9. Radical Intervention-free Survival

    Time frame: 5 years

    Free of Radical Prostatectomy or Radiation at 5 years

  10. 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

Secondary outcomes

  1. Intervention-Free Survival

    Time frame: 20 years

    Intervention (Focal or Whole Gland/ Radical)-free at 20 years

  2. Radical Intervention-Free Survival

    Time frame: 20 years

    Radical Intervention (Radical Prostatectomy or Radiation)-Free at 20 years

  3. Failure-Free Survival

    Time frame: 10 years

    Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 10 years

  4. Failure-Free Survival

    Time frame: 20 years

    Failure (Whole Gland/ Radical intervention, use of Hormonal Therapy or transition to Watchful Waiting)-free at 20 years

Other outcomes

  1. Inter-modality Comparison of short-term Oncological Outcomes

    Time frame: 12 months

    Comparison of 12-month infield and outfield recurrence rates between different focal therapy modalities

  2. Inter-modality Comparison of Conversion to Radical Treatment Rates

    Time frame: 10 years

    Comparison of 10 year conversion to radical treatment (Radical Prostatecomy or Radiation) between different modalities

  3. Inter-modality Comparison of Treatment Failure Rates

    Time frame: 10 years

    Comparison of 10 year failure (Radical Prostatectomy or Radiation or Hormonal Therapy or transition to Watchful Waiting) between different modalities

  4. Inter-modality Comparison of Metastasis Rates

    Time frame: 10 years

    Comparison of 10 year metastasis-rate between different modalities

  5. Inter-modality Comparison of Sexual Function Outcomes

    Time frame: 12 months

    Comparing mean change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.

  6. Inter-modality Comparison of Urinary Function Outcomes

    Time frame: 12 months

    Comparing mean change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.

  7. Inter-modality Comparison of Bowel Function Outcomes

    Time frame: 12 months

    Comparing mean change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the best function) post-FT compared to baseline at 1,3, 6, 12 months between different modalities.

Study contacts

Contact information is provided by the study sponsor or research team.

Kae Jack Tay, MBBS

CONTACT

[email protected]

63214693

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer

Acronym: ProAMFocal

Important dates

Study start
2023
Primary completion
2028
Study completion
2048
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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