MRI-invisible prostate cancer: can PSMA PET-CT guide targeted focal therapy?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-centre, single-arm Phase II trial evaluating the use of pelvis-only ¹⁸F-PSMA-1007 PET-CT to identify MRI-invisible clinically significant prostate cancer (ISUP Grade Group 2-3) and direct focal ablation to those PET-positive sites. Eligible men aged ≥50 with localized, organ-confined disease and at least one MRI-invisible csPCa focus undergo PET-CT after enrollment, with a PET-positive lesion anatomically matched to the MRI-invisible biopsy-positive site determining eligibility for focal therapy. The study uses a dedicated pelvis PET-CT protocol, a five-point PET-score system, and requires PET-avid lesions (scores 3-5) to guide treatment. Focal therapy is performed under anesthesia, integrating the imaging data for targeted ablation. The trial adheres to ICH-GCP and the Declaration of Helsinki and is conducted at The University of Hong Kong and Queen Mary Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men aged ≥50 years
2. Life expectancy \>10 years
3. Histologically confirmed localized prostate cancer, ISUP Grade Group 2 or 3
4. At least one clinically significant cancer focus (≥1 systematic biopsy core with Grade Group 2-3) that is MRI-invisible, defined as:

   \- The corresponding sextant/region on mpMRI (performed within 6 months) shows PI-RADS v2.1 score 1 or 2, or no identifiable lesion that could account for the positive biopsy
5. Total of 1-2 discrete cancer foci (MRI-visible + PET-detected MRI-invisible) on study entry, with each MRI-visible focus having maximum diameter ≤15 mm on mpMRI
6. Organ-confined disease on mpMRI and no evidence of seminal vesicle invasion or lymph node/distant metastasis
7. Serum PSA \<20 ng/mL
8. Able to provide informed consent

Exclusion Criteria:

1. Previous treatment for prostate cancer (radiotherapy, surgery, focal therapy, androgen deprivation)
2. Prior pelvic radiotherapy for any cause
3. Contraindication to MRI or gadolinium contrast
4. Contraindication to PSMA PET-CT (e.g. severe claustrophobia, inability to lie flat)
5. Contraindication to general or spinal anaesthesia
6. Uncorrectable coagulopathy (INR \>1.5, platelet \<50×10⁹/L) or anticoagulant/antiplatelet therapy that cannot be stopped (low-dose aspirin 80-100 mg is permitted)
7. Active urinary tract infection or acute prostatitis
8. MRI-invisible focus located in a region where focal therapy would likely cause sphincter or rectal injury, as determined by biopsy mapping and anatomical constraints
9. Bladder pathology (bladder stone, bladder cancer) or known urethral stricture

Where it's running

• Queen Mary Hospital
  Hong Kong, 香港島, Hong Kong Recruiting

Study contacts

• Study coordinator: Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM
• Email: jslleung@hku.hk
• Phone: +852 2255 4852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

  This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07879820

• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

  This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.

  Recruiting Lithuanian University of Health Sciences · Kaunas · NCT07863986

• Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

  This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.

  Recruiting at 8 sites Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Benidorm, Alicante and 9 other locations · NCT07860528

• Multi-peptide Vaccination and PSMAxCD3 Antibody Therapy for Prostate Cancer with Biochemical Recurrence

  This phase 2 trial tests whether a PSMA-targeted bispecific antibody (CC-1), a prostate cancer peptide vaccine (VAC-XS15-PC01), or both can be given safely and help control biochemical recurrence after local therapy in men with prostate cancer.

  Recruiting Phase 2 University Hospital Tuebingen · Heidelberg, Baden-Wurttemberg and 3 other locations · NCT07860047

• Lutetium-177 Ludotadipep for advanced prostate cancer

  This study tests whether adding Lu-177 Ludotadipep to standard care helps men with metastatic castration-resistant prostate cancer live longer without their disease getting worse.

  Recruiting at 7 sites Phase 3 FutureChem · Gyeonggi-do and 7 other locations · NCT07853209

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.