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Compares treatment options 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?
AAA617 is an investigational medicine, being studied as a potential treatment for oligometastatic prostate cancer (ompc).
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 purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
- 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 AJCC M staging, PSMA PET/CT information...
- Participants must have a negative CI for M1 disease at screening. Note:
You likely can't join if
- Participants with de novo OMPC at screening
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or...
- Prior therapy with:
- 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...
See the full eligibility criteria
Who can join
- 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. For definition of PSMA...
- 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
- Participants must have a negative CI for M1 disease at screening. Note:
- 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. Two different readers will be involved, one reader for PSMA PET/CT scan and one reader for CI...
- 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
What rules you out
- 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...
- Prior therapy with:
- 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. Same...
- 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. However, participants with a prior history of malignancy that has been adequately...
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
- 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 as assessed by the investigator. Other protocol defined Inclusion/Exclusion may apply.
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Grand Rapids, Michigan, United States
- Royal Oak, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
+ 110 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 - 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?
Study sites include 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 124 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.