Phase II Study for Metastatic Castration-Resistant Prostate Cancer
This study is for men aged 18 or older with metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and no longer responds to hormone therapy. It's testing a new approach that combines targeted radiation (stereotactic ablative radiotherapy) with a special drug called Pluvicto (PSMA targeted radiopharmaceutical therapy). After these treatments, the study will stop the castration (hormone therapy) and then half of the participants will also receive topical testosterone (testosterone replacement). The main goal is to see how many participants are free from cancer progression after 6 months. The study is currently recruiting up to 60 participants.
- Study design
- This is a randomized, open-label Phase 2 study with two groups, involving 60 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to measure radiographic progression-free survival at 6 months.
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NCT06084338
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
Recruiting
PHASE2Ages 18+InterventionalTreatmentVA Office of Research and DevelopmentGovernment-funded
~60 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:stereotactic ablative radiotherapyPluvictotopical testosterone
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-month radiographic progression-free survival (rPFS)
Measured over 6-months
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
Illinois1
Indiana1
Michigan1
Study leadership
- Nicholas George Nickols, MD PhD · PRINCIPAL_INVESTIGATOR · VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject must be 18 years of age or older at the time the Informed Consent is signed
The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial
Pathologic diagnosis of prostate cancer of adenocarcinoma histology; presence small cell/neuroendocrine carcinoma is exclusionary
Metastatic disease as documented by:
Osseous metastases detected by technetium-99m (99mTc) planar bone scan or NaF PET scan, or CT scan at some point in patient's history
Soft tissue metastases documented on CT or MRI
PSMA avid metastatic disease as determined by 18F-DCFPyL: at least one lesion with PSMA avidity greater than that of liver (see Prescribing Information for Pluvicto)
Progressive castration resistant prostate cancer as defined by serum testosterone \< 50 ng/mL and one of the following:
PSA progression confirmed per Prostate Cancer Clinical Trials Working Group (PCWG3)
Radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) modified based on PCWG3, or radiographic progression of bone according to PCWG3
Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide
ECOG PS grade of 0-2
10 metastases detectable on molecular imaging (PSMA and FDG PET) and amenable to SBRT
20% of metastases that are FDG avid but PSMA negative
Metastases that are not detectable on PSMA and FDG PET do not count toward the total number of metastases, as they are presumed to represent adequately treated sites of disease
Life expectancy 6 months
Adequate organ function:
Hemoglobin (hgb) \> 8.0 g/dL
Absolute neutrophil count (ANC) \> 1500/ µL
Platelets \> 75,000/ µL
Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels \>1.5 x ULN
ALT and AST 3.0 x ULN ( 5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded)
Creatinine \< (2.0 mg/dL) during screening evaluation (\>2.0 is allowed if EGFR \>30 mL/min/1.73 m2)
Subject must agree to use contraception during the treatment period plus an additional 120 days after the last dose of study treatment and must refrain from donating sperm during this period
Exclusion
Visceral metastases including liver and brain (lung metastases are allowed)
Small cell/neuroendocrine carcinoma by hematoxylin and eosin light histology (immunohistochemical detection of rare/occasional cells that stain for neuroendocrine markers such as synaptophysin, neuron specific enolase, or chromogranin A is not sufficient to make a diagnosis of small cell/neuroendocrine carcinoma)
Anti-neoplastic therapies for prostate cancer must be completed \> 2 weeks prior to Day 1 (initiation of first dose of PSMA RLT)
Investigational agents must have been completed \> 4 weeks of Day 1
Participants with Grade 2 neuropathy may be eligible
Herbal and non-herbal products that may decrease PSA levels other than medical castration and megestrol (up to 40 mg/day is allowed) for hot flashes
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention within 4 weeks prior to starting therapy
History of non-prostate active malignancy requiring treatment in the 24 months prior to Day 1 except for non-muscle invasive urothelial cancer, non-melanoma skin cancer, or any cancer that in the opinion of the investigator has been adequately treated and will not interfere with study procedures or interpretation of results
Active infection or conditions requiring treatment with antibiotics
Symptomatic local recurrence in the setting of prior curative intent therapy (surgery and/or radiation to the prostate)
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
Current or impending cord compression or another indication for urgent palliative radiation therapy
What this trial measures
- 6-month radiographic progression-free survival (rPFS)6-months
6-month radiographic progression-free survival (rPFS) measured by conventional imaging from date of initiation of PSMA radiopharmaceutical therapy