NL-OMON55231CompletedPhase 3
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer - PYTHO
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Curium PET France
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •2. Age * 18 years.
- •3. Histopathological proven prostate adenocarcinoma per original diagnosis.
- •4. First suspected recurrence of prostate cancer based on rising
- •prostate-specific antigen (PSA) after initial curative therapy with radical
- •prostatectomy of PSA * 0.2 ng/mL confirmed by a subsequent PSA value of *0.2
- •ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2
- •ng/mL above the nadir after therapy regardless of the serum concentration of
- •5. Able and willing to provide informed consent and comply with protocol
- •requirements
- •6. Patient who can undergo all study procedures per Investigator*s point of
- •7. Patient with social insurance cover.
Exclusion Criteria
- •1. ECOG > 2
- •2. History of previous salvage therapies (including salvage radiotherapy or
- •salvage lymph node dissection)
- •3. History of adjuvant radiotherapy
- •4. History of cryotherapy, high-intensity focused ultrasound (HIFU)
- •5. Other active malignant tumour
- •6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or
- •7. Treatment with colchicine in the past 8 days or ongoing
- •8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5
- •days or ongoing
- •9. Unable to lie supine for imaging
- •10. Known allergy to investigational or reference products or to any excipients
- •11. Unable to provide written consent (linguistic or psychological inability)
- •12. Participation in another clinical study within one month prior to inclusion
- •13. Uncooperative, in the Investigator's opinion.
- •14. Subjects deprived of their freedom by administrative or legal decision or
- •who are under guardianship
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Study on PET/CT Imaging (scan) with 18F-DCFPyL (radioactive substance) of Prostate Cancer having recurred shown by increase in PSA blood levelPatients with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrenceMedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-000121-37-FRCYCLOPHARMA217
Active, not recruiting
Phase 1
A Study on PET/CT Imaging (scan) with 18F-DCFPyL (radioactive substance) of Prostate Cancer having recurred shown by increase in PSA blood levelEUCTR2020-000121-37-NLCurium PET France217
Unknown
Phase 3
A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate CancerProstate Cancer RecurrentNCT04734184Curium PET France217
Unknown
Phase 2
18F-DCFPyL PET-CT Scan and Prostate CancerProstate Cancer AdenocarcinomaNCT03852654Lida Jafari170
No Longer Available
Not Applicable
F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate CancerProstate AdenocarcinomaPSA Level Greater Than 0.2PSA Level Greater Than or Equal to TwoPSA ProgressionRecurrent Prostate CarcinomaNCT03501940Andrei Iagaru