BridgeMD
New treatment option for Prostate Cancer Recurrent
Official title PSMA-RLT in Biochemically Recurrent PCa
ClinicalTrials.gov ID: NCT06220188
What this study is testing
What is [177Lu]Lu-PSMA I&T?
[177Lu]Lu-PSMA I&T is an investigational medicine, being studied as a potential treatment for prostate cancer recurrent.
Also referred to as PSMA-RLT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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.
You likely can't join if
- Concomitant participation in any other treatment 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.
See the full eligibility 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.
- Concomitant participation in any other treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.