Table of contents
- Overview of the trials
- Who is being studied
- Trial design and phase
- What the trials measure
- Main study details
- Important terms for patients
Overview of the trials
These studies investigate 3,3-Diphosphono-1,2-Propanedicarboxylic Acid, Tetrasodium Salt (Dpd) in the setting of prostate cancer research, with both trials focused on PSMA-RLT, which means radioligand therapy directed at PSMA.[1][2]
Both trials are listed as Phase 2 and both are Authorised.[1][2]
Who is being studied
One trial includes patients with prostate carcinoma who have biochemical local recurrence after primary therapy with curative intent, but no radio-morphological local recurrence, meaning there is a blood test sign of return but no visible local recurrence on imaging.[1]
The other trial includes patients with oligometastatic prostate cancer diagnosed with [68Ga]Ga-PSMA-11 PET imaging and planned for radical prostatectomy.[2]
Trial design and phase
Both studies are interventional, so the research team gives a treatment and then measures the results.[1][2]
The first pilot study plans to enroll 26 patients, while the second pilot study plans to enroll 10 patients.[1][2]
As pilot studies, they are early studies designed to see whether the approach is promising and whether it can be studied further.[1][2]
What the trials measure
The first study measures PSA response, defined as a PSA decline of at least 50% from the baseline value, and it also measures therapy toxicity using blood count, kidney function, and liver function, graded with CTCAE version 5.0.[1]
The second study measures safety and toxicity of neoadjuvant PSMA-RLT and radical prostatectomy, and it also evaluates PSA response, imaging response, pathological response, and oncological outcomes.[2]
Main study details
The first trial is titled “[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.”[1]
Its brief summary says the study aims to evaluate PSA response to [177Lu]Lu-PSMAI&T-RLT and assess systemic therapy toxicity.[1]
The second trial is titled “Neoadjuvant [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostate cancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Pilot Study.”[2]
Its brief summary says the study will evaluate PSA, imaging, and pathological response, as well as oncological outcomes, in patients planned for radical prostatectomy.[2]
Important terms for patients
Baseline value means the starting measurement taken before treatment begins, so later results can be compared with it.[1]
Toxicity means harmful effects or damage linked to treatment, and in these studies it is checked with blood tests and organ function tests.[1]
Pathological response means how the tissue looks under the microscope after treatment or surgery.[2]
Oncological outcomes means cancer-related results, such as how the disease behaves after treatment.[2]
