The primary aim of this first line 177Lu-PSMA RLT study is to evaluate the clinical efficacy in castration resistant metastatic prostate cancer. Secondary aims are to assess the progression free survival (radiographic, clinical or PSA progression…
ID
Source
Brief title
Condition
- Metastases
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the therapy response defined as decline of PSA value of
> 50%.
Secondary outcome
Not applicable.
Background summary
A novel radiation-based treatment for PCa is radionuclide therapy targeting
Prostate-Specific Membrane Antigen (PSMA), a protein which is overexpressed in
PCa cells.[2] PSMA ligands can be labeled with radioisotopes such as the
beta-emitter Lutetium-177 (Lu-177). Treatment of patients with this compound
results in high radiation doses specifically on PSMA expressing tumors. This
therapy is called PSMA-specific radionuclide therapy (Lu-177-PSMA) and offers
several advantages above Radium-223 as it targets all tumor lesions in the
body, not only bone metastases. Moreover, PSMA-targeted radionuclide therapy is
PSMA-specific, which selectively limits radiation damage to PSMA-expressing
tissues and reduces damage to healthy tissues. Lu-177-PSMA therefore combines
high tumoricidal effects with low toxicity.
Study objective
The primary aim of this first line 177Lu-PSMA RLT study is to evaluate the
clinical efficacy in castration resistant metastatic prostate cancer. Secondary
aims are to assess the progression free survival (radiographic, clinical or PSA
progression free survival), the response to 177Lu-177 PSMA RLT (RECIST 1.1,
metabolic, biomarkers), the safety and tolerability, the health-related quality
of life assessment and pain assessment, and the overall survival.
Study design
This is a multicentric, single arm and open label phase II study.
Intervention
Treatment of mCRPC with a maximum of 6 cycles of 177Lu-PSMA-617 radioligand
therapy.
Study burden and risks
As standard of care, patients will undergo a 68Ga/18F-PSMA PET/CT scan prior to
inclusion. For this study, PSMA-PET/CT imaging will be performed after every
two cycles and about 6 and 12 months after completion of therapy.
A potential risk is the therapeutic injection with 177Lu-PSMA-617 itself, as it
is not yet completely clear what the short and longterm toxicity profile of
this new therapeutic approach is. However, it is important to note that
treatment with 177Lu-PSMA-617 shows potential in stabilization of previously
progressive disease.
Kent Avenue - Suite A1-100 3000
West Lafayette, Indiana 47906-1075
NL
Kent Avenue - Suite A1-100 3000
West Lafayette, Indiana 47906-1075
NL
Listed location countries
Age
Inclusion criteria
1. Male aged 18 or older with metastatic adenocarcinoma of the prostate;
2. Metastatic castrate-resistant prostate cancer without any previous treatments;
3. Progressive disease with rising PSA on 3 consecutive measurements, and PSA * 20 ng/mL;
4. Target or non-target lesions > 1.5 cm in diameter according to RECIST 1.1;
5. Significant PSMA avidity on 68Ga/18F-PSMA PET/CT
6. ECOG Performance status 0 to 2;
7. Adequate renal function;
8. Adequate bone marrow function;
9. Adequate liver function;
10. Willing and able to comply with all study requirements;
11. Signed, written informed consent.
Exclusion criteria
1. Known brain metastasis;
2. Site(s) of disease that show minimal PSMA expression;
3. Sjogren's syndrome;
4. Prior treatment with 177Lu-PSMA-617;
5. Prior chemotherapy or androgen receptor inhibition therapy;
6. Contraindications to the use of corticosteroid treatment;
7. Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer, and carcinoma in situ of the bladder;
8. Imminent spinal cord compression;
9. Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety;
10. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
11. Any condition which, in the opinion of the investigator, would preclude participation in this trial;
12. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
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 |
|---|---|
| EudraCT | EUCTR2018-003088-79-NL |
| CCMO | NL66722.091.18 |