The aim of the study is to investigate the effect of MDRT to the visible lesions in patients with omCRPC (up to 3 metastases and/or local recurrence) while continuing the ongoing systemic treatment. Progression is based on prostate specific membrane…
ID
Source
Brief title
Condition
- Metastases
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 6, 12-and 24-months NEST-FS.
• 6- and 12- months rPFS.
Secondary outcome
• Quality of Life (QoL) evaluated using the EORTC QLQ-C30 for health related
QoL and the EORTC PR-25 for prostate symptom specific QoL.
• Acute and late toxicity reported using both physician-reported score (CTCAE
v5) and patient-reported questionnaires (RTOG/EORTC).
• Overall survival (OS).
Background summary
In patients with metastatic prostate cancer (PCa) who receive androgen
deprivation therapy (ADT), the sensitivity to castration will eventually
disappear due to the selection of castration-refractory clones. This will lead
to the stage of metastatic castration-refractory prostate can-cer (mCRPC),
which is incurable and results in a median overall survival of 2-3 years. (1-6)
Treatment options for patients with mCRPC include several systemic agents, such
as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel,
cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and,
to a lesser extent, biochemical pro-gression traditionally imply a switch to
the next line systemic treatment (NEST).
Within patients with mCRPC, there is a subgroup showing oligo-progression,
defined as the progression of up to 3 lesions, including both metastatic and/or
local relapse. Oligoprogression reflects a heterogeneous treatment response,
which, in turn, reflects the heterogeneity of the clonogenic cells that give
rise to mCRPC.(7) Retrospective studies suggest that metastasis-directed
radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for
NEST.(8-19) Recently, promising results were published on the use of MDRT in
the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival
(NEST-FS) of 21 months in well-selected patients.(20)
Currently, in The Netherlands, patients with omCRPC are frequently referred and
treated with MDRT, but a clear treatment protocol and inclusion/selection
criteria are missing. Moreover, the exact benefit of MDRT in patients with
omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.
Study objective
The aim of the study is to investigate the effect of MDRT to the visible
lesions in patients with omCRPC (up to 3 metastases and/or local recurrence)
while continuing the ongoing systemic treatment. Progression is based on
prostate specific membrane antigen (PSMA) positron emission tomography (PET)
scan. Primary endpoints are NEST-FS and the radiological progression-free
survival (rPFS).
Study design
Single-arm prospective nonrandomised phase II trial.
Intervention
All patients eligible for the trial will be discussed at the multidisciplinary
urology tumor board. The choice for MDRT will be based on the localization and
size of the metastases, the nearby organs-at-risk, technical feasibility, any
previous treatment, as well as patient medical history and preferences. The
visible lesions (up to 3) will be treated with MDRT with a hypofractionated
schedule.
Study burden and risks
Patients will receive MDRT to the visible lesions (up to 3). The side effects
of MDRT are very mild and self-limiting. All patients participating in the
study will complete toxicity and QoL questionnaires at baseline and during the
treatment. In addition, there could be some additional imaging investigation
according to the advice of MDO board before inclusion and during follow-up as
in case of progression or clinical doubt on metastasis lesion one imaging
modality. The treatment protocol and radiotherapy schemes used will be the same
as standard of care protocols.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Adenocarcinoma of the prostate.
• mCRPC setting, with testosterone level < 50 ng/dl or 1.7 nmol/l.
• Oligoprogressive disease diagnosed on PSMA scan; defined as the progression
of pre-existing metastatic disease, and/or the appearance of new metastases
and/or the appearance of a local relapse with a maximum of 3 lesions in total.
• Patients currently treated with ADT, whether combined with another systemic
treatment such as ARTA, chemotherapy.
• For patients treated with chemotherapy, the course should be completed or
stopped before start MDRT.
• In case of treatment with ARTA, a minimal of 3 months response (PSA or
clinical response).
• WHO performance status 0-2.
• Age > = 18 years old.
• Patient should be presented at the multidisciplinary tumor board of the local
hospital in which the therapy will be given.
• Before patient registration, written informed consent must be given according
to ICH/GCO and national/local regulations.
Exclusion criteria
• Serum testosterone level > 50 ng/ml or > 1.7 nmol/l.
• Presence of more than 3 progressive/new metastatic lesions and/or local
recurrence (which counts for 1 lesion).
• Active malignancy other than prostate cancer that can potentially interfere
with the interpretation of the trial, except non-melanoma skin cancer or
non-invasive urothelial cell carcinoma.
• Local recurrence in the prostate after previous radiotherapy.
• Previous treatments (RT, surgery) or comorbidities making new treatment with
MDRT impossible.
• Disorder precluding understanding of trial information or informed consent or
signing informed consent.
• Evidence of PSMA-negative disease.
Design
Recruitment
Medical products/devices used
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 | NL87430.042.24 |