To compare the oncologic outcomes of PCa patients with an estimated risk of lymph node invasion of 5-20% according to the Briganti nomogram without metastases on PSMA PET/CT undergoing a radical prostatectomy (RP) with or without an ePLND.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Persistent PSA rate 6 months after radical prostatectomy (persistent PSA is
defined as a PSA value >= 0.1 ng/ml)
Secondary outcome
• Biochemical recurrence-free survival (BCR-FS) (BCR is defined as a PSA value
>= 0.2 ng/ml).
• Metastasis-free survival
• Incidence of lymphoceles and complications six months after RP (using
Clavien-Dindo classification)
• Incidence of adjuvant therapy (androgen deprivation therapy, radiation
therapy or salvage lymph node dissection)
• Functional outcomes (quality of life, continence, potency)
Background summary
An extended pelvic lymph node dissection (ePLND) is the most accurate staging
method to assess the presence of lymph node metastases in prostate cancer (PCa)
patients. The therapeutic value, however, remains unclear. Prospective
randomized trials to address this void are lacking.
Since in intermediate risk (and in some cases high risk) PCa the risk of nodal
metastases is generally below 25%, the vast majority of men undergo a procedure
that has no oncological benefit, but is not without toxicity.
Study objective
To compare the oncologic outcomes of PCa patients with an estimated risk of
lymph node invasion of 5-20% according to the Briganti nomogram without
metastases on PSMA PET/CT undergoing a radical prostatectomy (RP) with or
without an ePLND.
Study design
A monocenter, prospective, randomized controlled trial
Intervention
Randomization will be performed to determine whether patients will be submitted
to group 1 or 2. Patients in group 1 will undergo a radical prostatectomy with
an ePLND. Patients in group 2 will undergo a radical prostatectomy without an
ePLND. Post-surgery, PSA values will be measured to monitor treatment response.
Study burden and risks
Patients in the experimental arm of the study will be expected to have less
early side-effects of the prostatectomy since many of the early morbidity after
prostatectomy is related to the ePLND. Participation does not require extra
hospital visits or examinations and regular follow-up will be in place for both
arms. Furthermore, we do not expect to observe a difference in the persistent
PSA rate between patients that undergo a radical prostatectomy with or without
an ePLND. If a BCR occurs in patients, a Prostate-Specific Membrane Antigen
(PSMA) PET scan will be performed to detect the origin of the BCR, regardless
of the study arm the patients were in. In case of positive imaging during
follow-up, therapeutic options will be offered to patients (i.e. salvage lymph
node dissection, salvage radiation therapy or hormone deprivation therapy). The
benefit of the study is to gain insight into the value of ePLND and potentially
pave the way towards a better selection of PCa patients for an ePLND.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Male, aged >= 18 years
- Prostate cancer patients with a Briganti calculated risk of LN metastases
between 5-20% without evidence of metastases on PSMA PET/CT requiring an ePLND
in the standard treatment
- Scheduled for a (robot-assisted) laparoscopic radical prostatectomy
- Written informed consent
Exclusion criteria
- American Society of Anaesthesiology (ASA) classification > 3
- Patients with a contraindication for a lymphadenectomy
- Neoadjuvant hormone deprivation therapy
- Absence or withdrawal of an informed consent
- Evidence of metastases on PSMA PET/CT
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72195.031.19 |