EUCTR2022-004115-92-AT
Active, not recruiting
Phase 1
eoadjuvant [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostatecancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Study - Neoadjuvant PSMA-RLT in oligometastatic PCa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medical University of Vienna
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients must be adults between 18 and 75 years of age.
- •\- Oligometastatic PCa diagnosed using \[68Ga]Ga\-PSMA\-11 imaging defined as M1a and/or M1b positive with \=5 osseous metastases and/or M1c \=3 lung metastases
- •\- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0\-1
- •\- Patients must have adequate bone marrow reserve: WBC \=1\.5 x 109 /L, Platelets \=100 x 109 /L and Haemoglobin \=9 g/dL.
- •\- Patients must have adequate renal function with eGFR \= 50mL/min/1\.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of \=2\.5 g/dL.
- •\- Patients must be able to sign Informed Consent Form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 5
Exclusion Criteria
- •\- Concomitant participation in any other interventional trial.
- •\- Concurrent severe oncologic and medical conditions that result in patients not having a life
- •expectancy of longer than the duration of the trial.
- •\- Nonmetastatic PCa on \[68Ga]Ga\-PSMA\-11 imaging
- •\- more than 5 osseous metastases on \[68Ga]Ga\-PSMA\-11 imaging
- •\- visceral metastases, apart from lungs
- •\- Age \> 75 years.
- •\- Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
- •\- Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
- •\- Complete urinary out\-flow obstruction or severe unmanageable urinary incontinence
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) in patients with prostate cancer and biochemical but not radiomorphologic local recurrence after primary therapy with curative intention: a future planned phase II studyEUCTR2022-003713-11-ATMedical University of Vienna20
Completed
Phase 1
An early phase clinical trial evaluating the effectiveness of treatment of 177Lu-PSMA with idronoxil in men with castrate-resistant prostate cancer (LuPin Trial)ACTRN12618001073291St Vincent's Hospital Sydney56
Completed
Phase 1
Lutetium-177-PSMA-617 in Low Volume Metastatic Prostate CancerProstate NeoplasmNCT03828838Radboud University Medical Center10
Active, not recruiting
Phase 2
Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate CancerProstate CancerNCT04443062Radboud University Medical Center58
Active, not recruiting
Phase 1
Radioactive labeled PSMA therapy for advanced salivary gland cancerSalivary gland cancer. More specifically two subtypes: adenoid cystic carcinoma and salivary duct carcinoma.Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2019-003857-27-NLRadboudumc10