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New treatment option for Prostate Cancer
Official title Prospective Clinical Trial of 177Lu-P17-088 in the Treatment of Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07562438
What this study is testing
What is 177Lu-P17-088?
177Lu-P17-088 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
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
- PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. P17-088 is a novel albumin-binding PSMA-targeted radioligand.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
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 90, men only
You may be able to join if
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) mCRPC refers to prostate cancer that progresses despite serum testosterone at castrate levels...
- PSA \>1 ng/mL with two consecutive rises at least 1 week apart, each increase ≥ 50% above the nadir.
- Radiographic progression: Either two or more new bone lesions on bone scan, or soft tissue lesion progression as per RECIST 1.1 criteria. Progression...
- Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current...
- Patients who have not received, refused, or progressed after receiving at least 1 but no more than 2 prior taxane-based therapies. The taxane regimen...
You likely can't join if
- Inability to tolerate imaging procedures;
- Patients who have received systemic anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy; excluding endocrine therapy)...
- Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months, or any...
- Patients with unresolved Grade 4 myelosuppression from prior anticancer therapy within 2 weeks, or Grade 3 myelosuppression requiring \>6 weeks for...
- Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study;
- Use of blood products or albumin within 14 days before dosing to meet enrollment criteria;
See the full eligibility criteria
Who can join
- Metastatic Castration-Resistant Prostate Cancer (mCRPC) mCRPC refers to prostate cancer that progresses despite serum testosterone at castrate levels (\< 50 ng/dL or 1.7 nmol/L), meeting at least one of the following...
- PSA \>1 ng/mL with two consecutive rises at least 1 week apart, each increase ≥ 50% above the nadir.
- Radiographic progression: Either two or more new bone lesions on bone scan, or soft tissue lesion progression as per RECIST 1.1 criteria. Progression based on symptoms alone is insufficient for mCRPC diagnosis and...
- Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current Guidelines:
- Patients who have not received, refused, or progressed after receiving at least 1 but no more than 2 prior taxane-based therapies. The taxane regimen must have included exposure for at least 2 cycles. Patients who...
- Patients who have progressed after receiving at least one novel androgen axis drug [NAAD] (e.g., abiraterone, enzalutamide).
- Ability to understand and voluntarily sign a written informed consent form (ICF), and willingness and ability to comply with trial procedures including examinations and follow-up.
- Age 18-90 years (inclusive).
- Expected survival \> 6 months.
- ECOG performance status ≤ 2.
- Presence of high-uptake lesions confirmed by 68Ga-PSMA-11 PET/CT imaging (positive defined as lesion uptake \>1.5 times the liver background).
- At least one measurable lesion per RECIST 1.1 criteria OR at least one bone metastasis per PCWG3 criteria.
- Adequate organ function (No blood products, growth factors, or albumin administered within 14 days prior to baseline lab tests):
- Bone Marrow Function: Neutrophil count ≥ 1.5 × 10#/L, White blood cell count ≥ 3.0 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, Hemoglobin ≥ 10 g/dL (≥ 100 g/L).
- Liver Function: Albumin ≥ 30 g/L, Total bilirubin ≤ 1.5 × ULN, ALT or AST ≤ 3.0 × ULN (without liver metastases) or ≤ 5.0 × ULN (with liver metastases).
- Renal Function: Serum creatinine ≤ 1.5 × ULN.
- Agreement to comply with prescribed radiation protection measures during the trial period.
What rules you out
- Inability to tolerate imaging procedures;
- Patients who have received systemic anticancer therapy (e.g., chemotherapy, radiotherapy, immunotherapy; excluding endocrine therapy), investigational drugs, or device therapy within 4 weeks prior to dosing;
- Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months, or any External Beam Radiation Therapy (EBRT) within 2 months prior to the...
- Patients with unresolved Grade 4 myelosuppression from prior anticancer therapy within 2 weeks, or Grade 3 myelosuppression requiring \>6 weeks for recovery;
- Planned use of cytotoxic chemotherapy, antitumor immunotherapy, radioligand therapy, or similar agents during the study;
- Use of blood products or albumin within 14 days before dosing to meet enrollment criteria;
- Brain metastasis at screening, except:
- Asymptomatic cases confined to supratentorial/cerebellar regions (no midbrain/pons/medulla/spinal cord involvement) without corticosteroid therapy and with lesions ≤1.5 cm;
- Symptomatic cases with treated and radiologically stable lesions (\>4 weeks);
- Other malignancies within 5 years (excluding cured localized cancers like basal/squamous cell skin carcinoma);
- Superscan on bone scintigraphy;
- Symptomatic or impending spinal cord compression;
- Prior EBRT involving extensive bone marrow (\>25%);
- Significant cardiac disease at screening, including:
- QTcF \>470 ms or long QT syndrome history;
- Myocardial infarction, angina, or CABG within 6 months deemed ineligible by investigators;
- Any condition that, per investigator judgment, may compromise safety, data interpretation, or indicate high risk;
- Uncontrolled bladder outlet obstruction, urinary incontinence, claustrophobia, or radiophobia at screening;
- Positive for HCV-Ab, HIV, or syphilis antibodies at screening;
- HBsAg-positive patients with active HBV replication (confirmed by HBVDNA per investigator assessment);
- Known allergy to proteins/peptides, excipients, or structurally related compounds;
- History of drug/alcohol abuse within 1 year or chronic substance abuse;
- Failure to use effective contraception during the trial and for 6 months post-last dose;
- Severe active infection prior to the first administration.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. 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.