NCT04775602CompletedPhase 2
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.
Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 550 (actual)
- First submitted
- 21 Jan 2020
- Start date
- 31 Jul 2020
- Primary completion date
- 5 Apr 2023
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Diseases
- Prostate cancer
- NCT number
- NCT04775602
- EudraCT number
- 2019-002000-41
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 550
- From 31 Jul 2020 to the primary completion date, 5 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No radiotherapy in the last 6 months.
- Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- Medical or psychological conditions that would not permit the subject to sign the informed consent
Other
- Hormonotherapy in the last 6 months
Who the study is looking for
- Patients must have histologically or cytologically confirmed prostate cancer
- Male, aged \>18 years on the day of signing and dating the informed consent form.
- Previous radical treatment for prostate cancer (radiotherapy or surgery)
- Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
- Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
- Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Participant is willing and able to give informed consent for participation in the study.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Irst-Irccs Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.