CompletedNot Applicable

F-18-Fluorocholine PET/CT and MR Imaging/ Spectroscopy in the Management of Primary and Recurrent Prostate Cancer

Switzerland60 participantsStarted 2009-08

Plain-language summary

The purpose of this study is to demonstrate that realization of guided biopsies by multimodal imaging with 18F-fluorocholine PET / CT and MR Imaging/spectroscopy would allow to increase the rate of detection prostate cancer compared with the current approach and give an information about location and tumoral volume before surgery.:

Who can participate

Age range

80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

PRIMARY PROSTATE CANCER Inclusion Criteria: * Age ≤ 80 years * Karnofsky index ≥ 80 * First prostate biopsy * Presence of at least one of the following: * Total PSA 10 ng/mL * Total PSA 2.5-10 ng/mL with free-PSA \<20% and/or PSA velocity 0.75 ng/mL/year * Suspicious hypoechoic lesion at TRUS and/or suspicious finding at digital rec¬tal examination * Informed signed consent. Exclusion Criteria: * Impaired capacity to consent * Coexistence of clinically-proven prostate cancer * Neoadjuvant hormonal treatment (including 5-α reductase inhibitors) * Contraindications to surgery * Contraindications to MR Imaging (see below) PROSTATE CANCER RELAPSE Inclusion Criteria: * Age ≤ 90 years * Karnofsky index ≥ 80 * Previous treatment for prostate cancer * No clinical recurrence based on standard work-up (abdominal / pelvic CT, MRI, and bone scintigraphy) * Biochemically proven relapse of prostate cancer (PSA \> 0.2 ng/mL after prostatectomy, nadir PSA+2 ng/mL (Phoenix definition) or ≤ 3 successive rising PSA levels (ASTRO definition) after curative radiotherapy). * Informed signed consent. Exclusion Criteria: * Coexistence of another clinically-proven cancer * Contraindications to surgery or radiation therapy treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity and specificity of FCH PET/CT, MR imaging, 3-D MR spectroscopy, and fusion PET/MR imaging for the intraprostatic localization of cancer in patients with radical prostatectomy as compared to histology as the gold standard

Timeframe: After prostatectomy (week 7-9 if Gleason score ≥ 8, week 7-15 if Gleason <8)

For prostate cancer patients with relapse: To determine the impact of FCH-PET imaging for localizing relapse patients in patients with biochemical failure as compared to the standard clinical workup

Timeframe: After PET/CT, week 1-2

Trial details

NCT IDNCT00963755

SponsorUniversity of Lausanne Hospitals

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12

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