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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed prostate cancer that has progressed to mCRPC with no grade 2 or above cancer related symptoms.

Participants need to have either PSA or imaging progression at castrate level of serum testosterone (i.e. <50ng/dl). The definition of PSA progression and the definitions of imaging progression on measurable or non-measurable lesions will be based on the prostate cancer working group 3 (PCWG3) criteria. Patients with symptomatic oligo progression (1-3 sites), the symptoms need to be improved to grade 1 or less with palliative local therapy prior to study enrollment.

Participants need to have a positive PSMA PET scan and deem eligible for PSMA-617.

Allowable prior therapies: Prior treatment with one line of ARPI. Patients need to be on ARPI for at least 4 weeks to be considered one line of therapy. Prior treatment with sipuleucel-T for mCRPC. Prior treatment with docetaxel in the castration sensitive setting.

Disqualifiers

Metastatic prostate cancer with known epidural, liver or brain metastases.

No history of cord compression.

Treatment with radiation within 30 days prior to the first dose of Tc400.

Receiving any other investigation agents. Prior treatment with investigation agents need to have a washout period of 4 weeks prior to enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Testosterone cypionate (Tc)

    Drug

    IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.

  • ADT with Luteinizing hormone-releasing hormone (LHRH) analog

    Drug

    Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.

  • PSMA-617

    Drug

    IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Single Arm: Tc400 followed by PSMA-617 (with continued ADT)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Tc400 and PSMA-617

Percentage of patients who can complete 3 doses of Tc400 followed by at least 2 doses of PSMA-617.

Time frame
Up To 6 Months

Secondary outcomes

1

Reduction in P/T ratio

Percentage of evaluable patients with 50% reduction in P/T ratio (PT50) compared to baseline P/T ratio based on PSA and testosterone values at screening.

Time frame
Up To 6 Months
2

PSA50 and PSA 90

Percentage of patients who achieved PSA50 and PSA 90 responses after two doses of PSMA-617 compared to the pre PSMA-617 PSA values at day 60.

Time frame
Up To 6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Source ClinicalTrials.gov
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