Trial comparing treatments for Oligometastatic Prostate Cancer (OMPC)
Official title An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
ClinicalTrials.gov ID: NCT05939414
What this study is testing
What is AAA617?
An investigational radiopharmaceutical being studied for oligometastatic prostate cancer. is designed to deliver targeted radiation to prostate cancer cells expressing PSMA.
Also referred to as (177Lu) vipivotide tetraxetan.
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
- The study aims to see how well and how safely lutetium‑vipivotide works for patients whose prostate cancer has spread to a few sites after initial treatment.
- Who it's for
- Men who have oligometastatic prostate cancer that has progressed after definitive treatment of the primary tumor.
- What's involved
- Participants receive the lutetium‑vipivotide drug, which is given as a series of injections.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 100, men only
You may be able to join if
- Histologically confirmed prostate cancer prior to randomization
- Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with...
- Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or...
- At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening.
- For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings...
You likely can't join if
- Participants with de novo OMPC at screening
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening.
- ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment
- Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary...
- Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT...
- Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or...
See the full eligibility criteria
- Histologically confirmed prostate cancer prior to randomization
- Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam...
- Participants must have OMPC with 1-5 PSMA -positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC.
- At least 1 PSMA-positive lesion must be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET/CT information should be used
- For a participant not to be eligible, CI positive M1 lesions should be unequivocal in CI scans, i.e., potentially not attributable to findings thought to represent something other than tumor (e.g., degenerative, or...
- Prior knowledge of PSMA PET positivity should not influence the radiologist (reader) in determination of CI positivity.
- MRI for radiation treatment planning may show M1 disease but this will not exclude the participant from the study if the lesion is deemed negative per baseline CT or bone scans
- Participants with pelvic disease (N1) seen in CI are allowed if the local spread is below common iliac bifurcation (per AJCC 8 definition of local disease)
- Distant lymph node disease (M1a) that is visible per CI and less than 10mm in the short axis is not exclusionary irrespective of PSMA PET positivity.
- If a previously surgically removed lesion was unequivocal for M1 by bone scan or CT, the participant is not eligible.
- All metastatic lesions detected at screening must be amenable to SBRT
- Non-castration testosterone level \>100 ng/dL at screening Key
- Participants with de novo OMPC at screening
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best...
- ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment
- Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months...
- Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was...
- Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant/neoadjuvant therapy are eligible provided that they discontinued...
- Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants)
- Other hormonal therapy. e.g., Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment.
- 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 \> 12 months before randomization
- Any other investigational or systemic agents for metastatic disease
- Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization
- Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy...
- Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment.
- Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker
- History of familial long QT syndrome or known family history of Torsades de Pointe
- Participants in immediate need of ADT or other systemic therapy as assessed by the investigator. In addition, investigators should only enroll participants who are committed to delay castration in accordance with the...
The study team makes the final eligibility decision.
Where it is enrolling
- Fayetteville, Arkansas, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Pensacola, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Elk Grove, Illinois, United States
- Des Moines, Iowa, United States
- Kansas City, Kansas, United States
- Baton Rouge, Louisiana, United States
- Metairie, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Royal Oak, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
+ 105 more site(s).
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, but 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 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fayetteville, Arkansas, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Jacksonville, Florida, United States and 119 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.