Prostate CancerPhase 2NCT07562438
Phase 2 Clinical Trial of 177Lu-P17-088 for mAPMR Prostate Cancer
A Phase 2 study testing 177Lu-P17-088 in people with Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. P17-088 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 177Lu-labeled P17-088 for treating patients with PSMA-positive metastatic androgen pathway modulation resistant (mAPMR)… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 177Lu-P17-088
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- metastatic androgen pathway modulation resistant (mAPMR) prostate cancer refers to Prostate cancer with distant metastases and sustained castrate testosterone (< 50 ng/dL or 1.7 nmol/L) during APM therapy, meeting ≥1 criterion:
- PSA nadir ≥1.0 ng/mL, absolute PSA rise ≥0.2 ng/mL confirmed ≥21 days apart;
- Radiographic progression: RECIST 1.1 soft tissue progression, or bone scan progression per PCWG4 2+2 rule (≥6 new bone lesions confirmed on single scan); PSMA-PET new metastatic lesions also qualify as progression.
- 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 received only one taxane may be included if the investigator deems them unsuitable for a second taxane (e.g., due to frailty assessed by geriatric/comorbidity evaluation or intolerance).
- Patients who have progressed after receiving at least one novel androgen axis drug [NAAD] (e.g., abiraterone, enzalutamide).
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- 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 soft tissue lesion per RECIST version 1.1 criteria, OR at least one bone metastasis on bone scintigraphy, OR at least one PSMA-positive metastatic lesion on PSMA-PET/CT, all as defined by PCWG4.
- 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 × 10^9/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.
Who cannot join
- 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 first dose;
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: A Prospective, Phase 2 Clinical Trial of 177Lu-P17-088 Therapy in Patients With Metastatic Androgen Pathway Modulation Resistant Prostate Cancer
PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. P17-088 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 177Lu-labeled P17-088 for treating patients with PSMA-positive metastatic androgen pathway modulation resistant (mAPMR) prostate cancer.
Read the detailed description
Radioligand therapy (RLT) targeting prostate-specific membrane antigen (PSMA) has demonstrated promising potential for the treatment of metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Conjugation of albumin-binding moieties to PSMA-targeted radioligands can prolong their circulating half-life in the blood, thereby markedly enhancing tumor uptake and therapeutic efficacy. P17-088 incorporates a pegylated p-iodophenylbutanoyl group as an albumin binder with moderate binding affinity yet superior overall performance, which achieves a refined balance between augmented tumor accumulation and favorable safety profiles.
In our preliminary first-in-human study, 177Lu-P17-088 was observed to exhibit elevated distribution in organs including the red bone marrow and kidneys, with a considerably higher accumulation magnitude in tumor lesions. Satisfactory therapeutic outcomes were achieved even at a low activity dose of 1.11 GBq, validating its potential for further clinical translational research.
This single-arm study is designed to further evaluate the safety and efficacy of low-dose 177Lu-P17-088 in mAPMR prostate cancer patients. 177Lu-P17-088 will be administered at a fixed activity of 3.7 GBq (±10%) once every 6 to 8 weeks, with a total of four planned treatment cycles.
Post-treatment follow-up (safety and efficacy): Upon discontinuation of treatment, all enrolled participants will undergo systematic safety surveillance, including a 30-day short-term safety follow-up (FUP) assessment and extended long-term safety monitoring for approximately 12 months.
Survival follow-up: Following the termination of study treatment or completion of the post-treatment follow-up period, participants' vital status will be collected via telephone contact every 90 days as part of survival surveillance. Strict adherence to the survival follow-up schedule shall be ensured to facilitate complete survival data acquisition. Survival follow-up and the overall study will be concluded once the required number of overall survival (OS) events for the final survival analysis is reached.
- Conditions
- Prostate Cancer
- Being tested
- 177Lu-P17-088
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-P17-088Drug
administered intravenously once every 6-8 weeks (1 cycle) for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-P17-088 | Experimental | Participant will receive 3.7 GBq (+/- 10%) 177Lu-P17-088, once every 6-8 weeks for a planned 4 cycles Receives: Drug: 177Lu-P17-088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-specific antigen 50 (PSA50) response
PSA50 response is defined as the proportion of patients who have a more/equal 50% decrease in PSA from baseline, it will be calculated at 12, 24 and 48 months
Measured: From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)
Number of participants with Treatment Emergent Adverse Events
The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
Dosimetry Data of Tumor and Organs
Absorbed Dose of 177Lu-P17-088 for Internal Irradiation in Tumors and Organs Based on SPECT/CT
Measured: After administration of 177Lu-P17-088, serial SPECT/CT scans are acquired at Day 0, Day 1, Day 2, Day 3, Day5, and absorbed dose is calculated based on these images.
Secondary outcomes (2)
Progression Free Survival (PFS)
PSA-PFS is defined as the time from date of enrollment to the date of first documented progression by investigator assessment (radiographic progression, clinical progression, PSA progression) or death from any cause, whichever occurs first.
Measured: From date of enrollment until date of progression or date of death from any cause, whichever come first, assessed up to 50 months (estimated final OS analysis)
Overall Survival (OS)
OS is defined as time to death for any cause.
Measured: From date of enrollment until date of death from any cause, assessed up to 50 months (estimated final OS analysis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start29 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Study chair, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562438
- Sponsor's protocol ID
- FirstAHFujian-177Lu-P17-088
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Phase 2 Clinical Trial of 177Lu-P17-088 Therapy in Patients With Metastatic Androgen Pathway Modulation Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07562438
- Acronym / sponsor ID
- FirstAHFujian-177Lu-P17-088
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. P17-088 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 177Lu-labeled P17-088 for treating patients with PSMA-positive metastatic androgen pathway modulation resistant (mAPMR) prostate cancer.
Detailed description
Radioligand therapy (RLT) targeting prostate-specific membrane antigen (PSMA) has demonstrated promising potential for the treatment of metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. Conjugation of albumin-binding moieties to PSMA-targeted radioligands can prolong their circulating half-life in the blood, thereby markedly enhancing tumor uptake and therapeutic efficacy. P17-088 incorporates a pegylated p-iodophenylbutanoyl group as an albumin binder with moderate binding affinity yet superior overall performance, which achieves a refined balance between augmented tumor accumulation and favorable safety profiles.
In our preliminary first-in-human study, 177Lu-P17-088 was observed to exhibit elevated distribution in organs including the red bone marrow and kidneys, with a considerably higher accumulation magnitude in tumor lesions. Satisfactory therapeutic outcomes were achieved even at a low activity dose of 1.11 GBq, validating its potential for further clinical translational research.
This single-arm study is designed to further evaluate the safety and efficacy of low-dose 177Lu-P17-088 in mAPMR prostate cancer patients. 177Lu-P17-088 will be administered at a fixed activity of 3.7 GBq (±10%) once every 6 to 8 weeks, with a total of four planned treatment cycles.
Post-treatment follow-up (safety and efficacy): Upon discontinuation of treatment, all enrolled participants will undergo systematic safety surveillance, including a 30-day short-term safety follow-up (FUP) assessment and extended long-term safety monitoring for approximately 12 months.
Survival follow-up: Following the termination of study treatment or completion of the post-treatment follow-up period, participants' vital status will be collected via telephone contact every 90 days as part of survival surveillance. Strict adherence to the survival follow-up schedule shall be ensured to facilitate complete survival data acquisition. Survival follow-up and the overall study will be concluded once the required number of overall survival (OS) events for the final survival analysis is reached.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-P17-088 | Experimental | Drug: 177Lu-P17-088Participant will receive 3.7 GBq (+/- 10%) 177Lu-P17-088, once every 6-8 weeks for a planned 4 cycles |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- metastatic androgen pathway modulation resistant (mAPMR) prostate cancer refers to Prostate cancer with distant metastases and sustained castrate testosterone (< 50 ng/dL or 1.7 nmol/L) during APM therapy, meeting ≥1 criterion:
- Failure of, Refusal of, Absence of, or Refractoriness to Standard Therapy, or Disease Progression, or No Available Standard Therapy per Current Guidelines:
- 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.
Key exclusion criteria (24 listed)
- 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 first dose;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-P17-088administered intravenously once every 6-8 weeks (1 cycle) for 4 cycles | Drug | 177Lu-P17-088 |
Primary outcome
Prostate-specific antigen 50 (PSA50) response
Time frame: From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)
PSA50 response is defined as the proportion of patients who have a more/equal 50% decrease in PSA from baseline, it will be calculated at 12, 24 and 48 months
Number of participants with Treatment Emergent Adverse Events
Time frame: From enrollment till 30 days safety follow-up, assessed up to 50 months (estimated final OS analysis)
The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Dosimetry Data of Tumor and Organs
Time frame: After administration of 177Lu-P17-088, serial SPECT/CT scans are acquired at Day 0, Day 1, Day 2, Day 3, Day5, and absorbed dose is calculated based on these images.
Absorbed Dose of 177Lu-P17-088 for Internal Irradiation in Tumors and Organs Based on SPECT/CT
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: From date of enrollment until date of progression or date of death from any cause, whichever come first, assessed up to 50 months (estimated final OS analysis)
Overall Survival (OS)
Time frame: From date of enrollment until date of death from any cause, assessed up to 50 months (estimated final OS analysis)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Miao, MD study chair
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 177Lu-P17-088 in people with Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate-specific antigen 50 (PSA50) response (time frame: From date of randomization till 30 days safety fup, assessed up to 50 months (estimated final OS analysis)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.