This study has been transitioned to CTIS with ID 2023-507772-50-00 check the CTIS register for the current data. The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6 cycles at a dose of 7.4 Gigabecquerel (GBq) (200…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
prostaat kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate whether treatment with 177Lu-PSMA-617 improves the time to
radiographic progression by BICR according PCWG3-modified RECIST v1.1 or death
in participants with progressive PSMA-positive mCRPC compared to participants
treated with ARDT
Secondary outcome
key secondary:
To evaluate whether treatment with 177Lu-PSMA-617 improves the overall survival
(OS) in participants with progressive PSMA-positive mCRPC compared to
participants treated with ARDT treatment
other:
To estimate the time to radiographic progression by BICR or death in
participants treated with ARDT who subsequently crossover to 177Lu-PSMA-617
after radiographic progression (rPFS2)
for more see page 14 in the protocol
Background summary
The preliminary clinical evidence indicates that 177Lu-PSMA-617 may demonstrate
clinical benefit for men with mCRPC, improving rPFS and OS compared with a
change in ARDT. The ongoing VISION study is investigating the efficacy and
safety of 177Lu-PSMA-617 in mCRPC participants previously treated with ARDT and
taxane-based chemotherapy. Data from this study will complement the data from
the VISION study for 177Lu-PSMA-617 as a treatment in mCRPC prior to the use of
taxanes.
The basic principle of 177Lu-PSMA-617 radioligand therapy is to systemically
deliver low dose rate radiation specifically to multiple PSMA positive prostate
cancer lesions, while sparing normal tissues. To date, 12 dosimetry studies
have been conducted in 158 participants. The results are consistent across the
studies and demonstrate exposure that correlates well with the expected rapid
clearance of a small molecule, and the limited distribution pattern of a
PSMA-targeted radionuclide.
177Lu-PSMA-617 is well tolerated according to the clinical experience that has
been documented in over 53 publications, summarizing the safety and or efficacy
information from over 1280 participants
Study objective
This study has been transitioned to CTIS with ID 2023-507772-50-00 check the CTIS register for the current data.
The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6
cycles at a dose of 7.4 Gigabecquerel (GBq) (200 Millicuries (mCi)) +/- 10%,
improves the radiographic progression free survival (rPFS) or death compared to
a change in androgen receptor-directed therapy (ARDT) in metastatic castrate
resistant prostate cancer (mCRPC) participants that were previously treated
with an alternate ARDT and not exposed to a taxane-containing regimen in the
castrate resistant prostate cancer (CRPC) or metastatic hormone-sensitive
prostate cancer (mHSPC) settings.
Study design
This is a phase III, open label, multicenter randomized study for PSMA-positive
mCRPC participants previously treated with an ARDT where it is considered
appropriate to delay taxane-based chemotherapy.
The study aims at evaluating the superiority of 177Lu-PSMA-617 over a change of
ARDT treatment in prolonging rPFS. The primary endpoint of rPFS will be
assessed via blinded centralized review of radiographic images provided by the
treating physician and as outlined in PCWG3 Guidelines.
The study will also evaluate whether 177Lu-PSMA-617 improves the overall
survival (OS) in participants with progressive PSMA-positive mCRPC compared to
participants treated with a change in ARDT treatment. OS is defined as the time
from randomization to death due to any cause
Intervention
Intervention with 177Lu-PSMA-11 or anti-hormonal therapy and patients on
anti-hormonal therapy can cross over to 177Lu-PSMA-11 treatment
Study burden and risks
Risk: potential side effects of study treatment and GA-PSMA-11 scan
Burden:
The patient will come to the study doctor*s clinic 6 times during the first 1
cycle (1 cycle is 6 weeks), thereafter 3 times during each following 5 cycles,
thereafter every 12 weeks. After the patient discontinues study treatment,
he/she will be followed for safety.
See question E4 for all study assessments.
Haaksbergweg 16
Amsterdam 1101 BX
NL
Haaksbergweg 16
Amsterdam 1101 BX
NL
Listed location countries
Age
Inclusion criteria
• Participants must have an ECOG performance status of 0 to 1
• Participants must have histological pathological, and/or cytological
confirmation of adenocarcinoma of the prostate
• Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as
determined by the sponsor*s central reader
• Participants must have a castrate level of serum/plasma testosterone (< 50
ng/dL or < 1.7 nmol/L)
• Participants must have progressed only once on prior second generation ARDT
(abiraterone, enzalutamide, darolutamide, or apalutamide).
• first generation androgen receptor inhibitor therapy (e.g. bicalutamide) is
allowed but not considered as prior ARDT therapy
• second generation ARDT must be themost recent therapy received
• Participants must have progressive mCRPC. Documented progressive mCRPC will
be based on at least 1 of the following criteria:
• Serum/plasma PSA progression defined as 2 increases in PSA measured at least
1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng.mL is the minimal
starting value if confirmed rise in PSA is the only indication of progression
• Soft-tissue progression defined [PCWG3-modified RECIST v1.1 (Eisenhauer et al
2009, Scher et al 2016)]
• Progression of bone disease: two new lesions; only positivity on thebone scan
defines
metastatic disease to bone (PCWG3 criteria (Scher et al 2016))
• Participants must have >= 1 metastatic lesion that is present on
screening/baseline CT, MRI, or bone scan imaging obtained <= 28 days prior to
beginning study therapy
• Participants must have recovered to <= Grade 2 from all clinically significant
toxicities related to prior therapies (i.e. prior chemotherapy, radiation,
etc.) except alopecia
• Participants must have adequate organ function
Exclusion criteria
- Previous treatment with any of the following within 6 months of
randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-
188, Radium-223, hemi-body irradiation
- Previous PSMA-targeted radioligand therapy
- Prior treatment with cytotoxic chemotherapy for castration resistant
or castrate sensitive prostate cancer (e.g., taxanes, platinum,
estramustine, vincristine, methotrexate, etc.), immunotherapy or
biological therapy [including monoclonal antibodies]) [Note: Taxane
exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is
allowed if 12 months have elapsed since completion of this adjuvant or
neoadjuvant therapy]. Prior treatment with sipuleucel-T is allowed
- Any investigational agents within 28 days prior to day of
randomization
- Known hypersensitivity to any of the study treatments or its
excipients or to drugs of similar classes
- Other concurrent cytotoxic chemotherapy, immunotherapy,
radioligand therapy, PARP inhibitor, biologicals or investigational therapy
- Transfusion or use of bone marrow stimulating agents for the sole
purpose of making a participant eligible for study inclusion
- Patients with a history of CNS metastases that are neurologically
unstable, symptomatic, or receiving corticosteroids for the purpose of
maintaining neurologic integrity. Participants with CNS metastases are
eligible if received therapy (surgery, radiotherapy, gamma knife),
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asymptomatic and neurologically stable without corticosteroids.
Participants with epidural disease, canal disease and prior cord
involvement are eligible if those areas have been treated, are stable, and
not neurologically impaired.
- Symptomatic cord compression, or clinical or radiologic findings
indicative of impending cord compression
- History or current diagnosis of the following ECG abnormalities
indicating significant risk of safety for study participants:
- Concomitant clinically significant cardiac arrhythmias, e.g. sustained
ventricular tachycardia, complete left bundle branch block, high-grade
AV block (e.g., bifascicular block, Mobitz type II and third degree AV
block)
- History of familial long QT syndrome or known family history of
Torsades de Pointe
- Cardiac or cardiac repolarization abnormality, including any of the
following: History of myocardial infarction (MI), angina pectoris, or
CABG within 6 months prior to starting study treatment
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 |
|---|---|
| EU-CTR | CTIS2023-507772-50-00 |
| EudraCT | EUCTR2020-003969-19-NL |
| ClinicalTrials.gov | NCT04689828 |
| CCMO | NL75959.091.21 |