BridgeMD
An international prospective open-label, multi-center, randomized, non-comparative phase II study of lutetium [177Lu] vipivotide tetraxetan alone and lutetium [177Lu] vipivotide tetraxetan in combination with androgen receptor pathway inhibitors in patients with PSMA PET scan positive castration-resistant prostate cancer (PSMACare)
EU CTIS ID: 2022-503040-41-00
What this study is testing
To evaluate PSA response in participants with CRPC receiving AAA617 alone and participants receiving ARPI and AAA617
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be adults ≥ 18 years of age with signed informed consent prior to participation to study
- Histologically or cytologically confirmed prostate cancer
- Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy; intermittent androgen deprivation therapy (ADT) before study entry is also permitted if criterion for serum testosterone is met
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on continuous/intermittent GnRH agonist or antagonist therapy or after bilateral orchiectomy
- Participants must have evidence of PSMA-positive disease (N1 or M1) as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease on PSMA PET scan are allowed to participate
- Participants must have a negative conventional imaging for M1 disease.
You likely can't join if
- Prior or present evidence of metastatic disease as assessed locally by CT/MRI for soft tissue disease and whole-body radionuclide bone scan for bone disease. Exception: Participants with pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the common iliac bifurcation (N1) are eligible per AJCC 8 definition of local disease))
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed
- Active clinically significant cardiac disease: history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy
- Prior therapy with: second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide); CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole; radiopharmaceutical agents (e.g., Strontium-89), PSMA-targeted radioligand therapy; immunotherapy (e.g., sipuleucel-T); chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed > 2 years before randomization; any other investigational agents for CRPC; use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethamide) or first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization; radiation therapy (external beam radiation therapy [EBRT] and brachytherapy within 28 days before randomization
- Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy
See the full eligibility criteria
Who can join
- Participants must be adults ≥ 18 years of age with signed informed consent prior to participation to study
- Histologically or cytologically confirmed prostate cancer
- Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy; intermittent androgen deprivation therapy (ADT) before study entry is also permitted if criterion for serum testosterone is met
- Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on continuous/intermittent GnRH agonist or antagonist therapy or after bilateral orchiectomy
- Participants must have evidence of PSMA-positive disease (N1 or M1) as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease on PSMA PET scan are allowed to participate
- Participants must have a negative conventional imaging for M1 disease.
- Participants must have adequate organ functions: bone marrow reserve, hepatic & renal
What rules you out
- Prior or present evidence of metastatic disease as assessed locally by CT/MRI for soft tissue disease and whole-body radionuclide bone scan for bone disease. Exception: Participants with pelvic disease may be eligible (e.g., participants with enlarged lymph nodes below the common iliac bifurcation (N1) are eligible per AJCC 8 definition of local disease))
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed
- Active clinically significant cardiac disease: history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy
- Prior therapy with: second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide); CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole; radiopharmaceutical agents (e.g., Strontium-89), PSMA-targeted radioligand therapy; immunotherapy (e.g., sipuleucel-T); chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed > 2 years before randomization; any other investigational agents for CRPC; use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethamide) or first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization; radiation therapy (external beam radiation therapy [EBRT] and brachytherapy within 28 days before randomization
- Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy
The study team makes the final eligibility decision.
Where it's taking place
- China
- Korea, Republic of
- United States
- Singapore
- Canada
- Brazil
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Korea, Republic of; United States; Singapore; Canada; Brazil. 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 EU CTIS; the study team decides eligibility.