Using a special imaging technique to plan treatment for prostate cancer patients
Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer
This study is testing a special imaging technique to see if it can help doctors better plan treatment for men with high-risk prostate cancer or those whose cancer has come back after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Medical University of Bialystok Academic / other |
| Locations | 7 sites (Bialystok and 6 other locations) |
| Trial ID | NCT05582876 on ClinicalTrials.gov |
What this trial studies
This multicenter trial evaluates the diagnostic value of the radiotracer 68Ga-PSMA-11 in PET/CT and PET/MR imaging for patients with high-risk and intermediate prostate cancer. It aims to assess its effectiveness in therapy planning before radical treatment and in patients experiencing biochemical recurrence after such treatment. The study includes patients diagnosed with prostate adenocarcinoma and those with biochemical recurrence, ensuring they meet specific eligibility criteria related to cancer risk and kidney function.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with medium to high-risk prostate cancer or those experiencing biochemical recurrence after radical treatment.
Not a fit: Patients with low-risk prostate cancer or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance personalized treatment planning for prostate cancer patients, potentially improving outcomes.
How similar studies have performed: Other studies using similar imaging techniques have shown promise in improving treatment planning for prostate cancer, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned * Prostate adenocarcinoma confirmed by biopsy and histopathological examination * Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score\> 7 or cT2c or PSA\> 20 ng / ml) risk according to ISUP * Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance\> 60 mL / min * Age ≥18 years * Signing informed consent to participate in the study * Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision: * Prostate adenocarcinoma confirmed by biopsy and histopathological examination * After radical treatment * In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) \<3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or * In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml * Age ≥18 years * Signing informed consent Exclusion Criteria: * Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination * Claustrophobia * Patient size precluding PET / MR examination due to diameter gantry * Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation) * Treatment for malignant neoplasm not associated with the prostate gland * Participating in another clinical trial * Lack of informed consent to participate in the study * Age \<18 years
Where this trial is running
Bialystok and 6 other locations
- Białystok Oncology Center Maria Skłodowska-Curie — Bialystok, Poland (Recruiting)
- University Clinical Hospital in Białystok — Bialystok, Poland (Recruiting)
- Independent Public Health Care Center of the Ministry of Internal Affairs and Administration in Białystok — Bialystok, Poland (Not_yet_recruiting)
- Laboratory of Molecular Imaging and Technology Development — Bialystok, Poland (Recruiting)
- Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz — Bydgoszcz, Poland (Recruiting)
- Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus University in Łódź — Lodz, Poland (Not_yet_recruiting)
- Center of Oncology of the Lublin Region St. Jana z Dukli — Lublin, Poland (Recruiting)
Study contacts
- Study coordinator: Ewa Sierko, Professor
- Email: ewa.sierko@iq.pl
- Phone: 85 664 67 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.