Clinical trial NCT06220188: PSMA-RLT in Biochemically Recurrent PCa
Official title: [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Recurrent
Keywords: [177Lu]Lu-PSMA I&T
PSMA-radioligand therapy
Biochemical recurrence
Prostate cancer
PSA value
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-center one-arm phase II study
Primary purpose: TREATMENT

Brief summary: Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA \> nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.


Eligibility criteria: Inclusion Criteria:

* Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.
* No hormonal therapy within the last 12 months or recovered testosterone levels.
* PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
* 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.

Exclusion Criteria:

* Concomitant participation in any other interventional trial.
* Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year.
* 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.

Primary outcomes:
measure: PSA response
timeFrame: 12 months
measure: Emergence of therapy toxicity
timeFrame: 12 months
Secondary outcomes:
measure: Time to PSA value progression
timeFrame: 18 months
measure: androgen deprivation therapy- and other treatment-free survival
timeFrame: 18 months
measure: Evaluation of life quality of the treated patients
timeFrame: 18 months
measure: Assess time to imaging progression
timeFrame: 18 months
measure: Quantification of circulating free tumor DNA
timeFrame: 18 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: