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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Salvage Lymphnode dissection
Sponsored by
Martini-Klinik am UKE GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer recurrence, salvage lymph node dissection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Martini-Klinik am UKE GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Unilateral lymphnode dissection

bilateral Lymphnode dissection

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of complete biochemical response
cBR: PSA <0.2ng / ml after salvage lymph node dissection without adjuvant prostate cancer specific therapy

Secondary Outcome Measures

Prostate cancer-specific therapy-free survival
e.g. medicinal, radiotherapy, operative

Full Information

First Posted
February 12, 2020
Last Updated
April 11, 2023
Sponsor
Martini-Klinik am UKE GmbH
Collaborators
University Hospital Hamburg, Institute of Tumor Biology
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1. Study Identification

Unique Protocol Identification Number
NCT04271579
Brief Title
Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s)
Acronym
ProsTone
Official Title
Early Prostate Cancer Recurrence With PSMA PET Positive Unilateral Pelvic Lesion(s): is One-sided Salvage Extended Lymph Node Dissection Enough
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Martini-Klinik am UKE GmbH
Collaborators
University Hospital Hamburg, Institute of Tumor Biology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Significant advances in molecular nuclear medicine imaging in prostate cancer have been achieved in recent years. In particular, the introduction of prostate-specific membrane antigen (PSMA) -based tracers has significantly influenced diagnostic imaging of prostate. If cancer recurs after surgical removal of the prostate, targeted PSMA PET (positron emission tomography) can detect metastases even at very low PSA (prostate-specific Antigen) values. This increasingly allows individualized specific therapy of patients with prostate cancer recurrence. PSMA PET has now been included in national and international guidelines for the diagnosis of patients with biochemical recurrence of prostate cancer. Especially in patients in good general condition, with potentially longer life expectancy and early localized PSA recurrence, advances in molecular imaging are increasingly turning local therapy concepts into focus. Here both, radiotherapeutic (salvage radiotherapy of the lymphatic drainage) and surgical interventions (salvage lymph node dissection = removal of the pelvic lymph nodes) are offered on an individual basis. These regional therapies mainly aim to achieve a delay of further progression of the prostate cancer disease, and thus delay the initiation of palliative, sustained drug therapy. Previous standard or common practice at salvage lymph node dissection is the removal on both sides of the pelvic lymph nodes even if only one-sided suspicious lymph nodes are detected on imaging. Although the complications of salvage lymph node dissection are usually minor and manageable, they can still lead to impaired lymphatic drainage, leg edema, lymphocele formation or other surgical complications. 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 lymph node dissection.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer recurrence, salvage lymph node dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
397 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral lymphnode dissection
Arm Type
Active Comparator
Arm Description
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
Arm Title
bilateral Lymphnode dissection
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Salvage Lymphnode dissection
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rate of complete biochemical response
Description
cBR: PSA <0.2ng / ml after salvage lymph node dissection without adjuvant prostate cancer specific therapy
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Prostate cancer-specific therapy-free survival
Description
e.g. medicinal, radiotherapy, operative
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Maurer, PD Dr.
Phone
+49 (0) 40 7410 53115
Email
t.maurer@uke.de
Facility Information:
Facility Name
Martini-Klinik am UKE GmbH
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Graefen, Professor
Phone
+4904741051300
Email
graefen@uke.de
First Name & Middle Initial & Last Name & Degree
Anke Renter
Phone
+49047410533115
Email
a.renter@uke.de

12. IPD Sharing Statement

Plan to Share IPD
No

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

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