Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)
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- STATUS
- Recruiting
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- participants needed
- 397
-
- sponsor
- Martini-Klinik am UKE GmbH
Summary
Significant advances in molecular
Especially in patients in good general condition, with potentially longer life expectancy and
early localized PSA recurrence, advances in
These regional therapies mainly aim to achieve a delay of further progression of the prostate
The aim of the present study is to investigate whether a unilateral pelvic lymph node
dissection on the side of conspicuous PSMA PET is sufficient and a dissection on the
contralateral side can be dispensed without negatively impacting oncological outcomes and
thereby sparing the patient the potential additional complications of a bilateral pelvic
Description
In this prospective randomized study, patients with early biochemical recurrence after
- complete biochemical response (cBR: PSA <0.2ng /ml) after salvage
lymph node dissection - biochemical freedom from recurrence without further prostate-cancer-specific therapy
(time from salvage
lymph node dissection to first PSA value> 0.2ng / ml) - prostate cancer-specific therapy-free time (time from salvage
lymph node dissection to initiation ofprostate cancer specific therapy) In addition, the diagnostic accuracy of the preoperative PSMA PET, which led to the indication of salvagelymph node dissection , is to be investigated in the context of the study and the standardized one- or two-sided templatelymph node dissection . Furthermore, it should be investigated whether there is a reduction of surgery-associated side effects in patients undergoing unilateral salvagelymph node dissection . In addition, quality of life andpsychological stress of patients is systematically recorded by means of validated questionnaires. Since salvage lymph node dissection may also be carried out with the help of currently experimental preoperative labeling with PSMA ligands for easier intraoperative localization (PSMAradioguided surgery ), a comparison of conventionalsalvage surgery and the PSMAradioguided surgery is also planned. However, if applied to patients, PSMA radioguidedsurgery is performed outside of the study protocol and is explicitly not part of the study protocol.
In case there is no complete biochemical response (cBR, PSA <0.2ng / ml) or, after reaching cBR, a further increase in PSA above 0.2ng / ml threshold is observed after salvage lymph node dissection, an attempt should be made to localize recurrence disease using PSMA PET. This should provide indirect information as to whether re-irradiation following salvage lymph node dissection could be a useful approach and should be investigated in future studies. However, PSMA PET is recommended in the study, but is optional and therefore to be performed outside of the study protocol.
Details
Condition | Malignant neoplasm of prostate, Prostatic disorder |
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Age | 18years - 75years |
Treatment | Salvage Lymphnode dissection |
Clinical Study Identifier | NCT04271579 |
Sponsor | Martini-Klinik am UKE GmbH |
Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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