Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04271579

Studienbeginn:
Oktober 2019

Letztes Update:
12.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms, Recurrence

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Martini-Klinik am UKE GmbH

Collaborator:
University Hospital Hamburg, Institute of Tumor Biology

Kontakt

Tobias Maurer, PD Dr.
Kontakt:
Phone: +49 (0) 40 7410 53115
E-Mail: t.maurer@uke.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Martini-Klinik am UKE GmbH
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Markus Graefen, Professor
Phone: +4904741051300
E-Mail: graefen@uke.de

Anke Renter
Phone: +49047410533115
E-Mail: a.renter@uke.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

In this prospective randomized study, patients with early biochemical recurrence after

radical prostatectomy and with PSMA-PET positive unilateral pelvic metastatic lesions are

assessed as to whether unilateral and bilateral salvage lymph node dissection are

oncologically equivalent. For this, the following endpoints will be evaluated:

- 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 of prostate cancer specific therapy) In addition, the diagnostic accuracy of

the preoperative PSMA PET, which led to the indication of salvage lymph node dissection,

is to be investigated in the context of the study and the standardized one- or two-sided

template lymph node dissection. Furthermore, it should be investigated whether there is

a reduction of surgery-associated side effects in patients undergoing unilateral salvage

lymph node dissection. In addition, quality of life and psychological 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 (PSMA

radioguided surgery), a comparison of conventional salvage surgery and the PSMA

radioguided surgery is also planned. However, if applied to patients, PSMA radioguided

surgery 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients in good general condition with life expectancy> 10 years

- Hormone-sensitive prostate cancer recurrence after radical prostatectomy (patients

with status post salvage prostatectomy may be included; salvage radiotherapy for

prostate fossa and / or pelvic lymph drainage after radical prostatectomy is not an

exclusion criterion)

- Unilateral detection of ≤ 3 PSMA PET positive lymph node metastases in the pelvis (up

ot origin of the inferior mesenteric artery)

- PSA at the time of PSMA PET imaging <4 ng / ml

Exclusion Criteria:

- Contraindication for surgery or bilateral salvage lymph node dissection

- Suspected prostate cancer recurrence in the prostate fossa (local recurrence) or

extrapelvic metastasis on PSMA PET imaging

- Date of PSMA PET examination > 4 months prior to salvage lymph node dissection

- Hormone therapy within 6 months prior to study enrollment

Studien-Rationale

Primary outcome:

1. Rate of complete biochemical response (Time Frame - 24 months):
cBR: PSA <0.2ng / ml after salvage lymph node dissection without adjuvant prostate cancer specific therapy

Secondary outcome:

1. Prostate cancer-specific therapy-free survival (Time Frame - 12 months):
e.g. medicinal, radiotherapy, operative

Studien-Arme

Active Comparator: Unilateral lymphnode dissection
Salvage lymphnode dissection is performed on the PSMA PET positive side, according to template (obturator, iliac external, iliac internal, iliac commun) and possibly including other anatomical pelvic regions
Active Comparator: bilateral Lymphnode dissection
In addition, a salvage lymphnode dissection is performed on the opposite side with resection of the corresponding fields, which were taken on the PSMA-PET positive side

Geprüfte Regime

Salvage Lymphnode dissection:
A salvage lymphnode dissection is performed in all study patients (both arms)using standard surgical techniques (openly or DaVinci).In patients who were randomized to the bilateral pelvic lymphnode dissection group, a salvage lymphadenectomy was also performed on the opposite side with resection of the corresponding fields that were removed on the PSMA-PET positive side (th "Blinding" must be guaranteed during pathological assessment)

Quelle: ClinicalTrials.gov

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