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PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC

ConditionMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
SponsorWest China Hospital

About this trial

This is a multicenter, randomized, open-label phase 2 study for men with metastatic hormone-sensitive prostate cancer. About 254 participants will first receive 6 months of darolutamide plus androgen deprivation therapy. Participants whose cancer has not progressed and who still have active tumor lesions on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) will then be randomly assigned to one of two groups. One group will continue darolutamide plus androgen deprivation therapy. The other group will receive stereotactic body radiotherapy (SBRT) to all active tumor lesions identified by PSMA PET/CT, while continuing darolutamide plus androgen deprivation therapy. The main purpose of this study is to find out whether adding PSMA PET/CT-guided SBRT can help participants live longer without tumor growth seen on scans or death. The study will also evaluate prostate-specific antigen (PSA) changes, time to castration-resistant prostate cancer, overall survival, side effects, and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male participants aged ≥18 years and <85 years.

Histologically confirmed prostate adenocarcinoma.

No neuroendocrine carcinoma, ductal adenocarcinoma, small-cell carcinoma, signet-ring cell carcinoma, or sarcomatoid carcinoma component.

Metastatic prostate cancer confirmed by imaging and/or pathological evidence.

Disqualifiers

Current or prior history of another primary malignancy.

History of another malignancy within 3 years that differs from the study cancer in primary site or histology.

History of papillary thyroid carcinoma is allowed if it is well controlled.

History of basal cell carcinoma of the skin is allowed if it is well controlled.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic Body Radiotherapy (SBRT)

    Radiation

    Stereotactic body radiotherapy will be delivered in the experimental arm after the 6-month run-in period of darolutamide plus androgen deprivation therapy. Radiotherapy will target all residual PSMA PET/CT-positive active tumor lesions, while participants continue darolutamide plus androgen deprivation therapy. Target lesions may include active lesions in the prostate or prostate bed and metastatic sites. Dose and fractionation will be selected according to lesion location, lesion size, and organ-at-risk constraints as specified in the study protocol.

  • Darolutamide 600 mg twice daily

    Drug

    Darolutamide will be administered orally at 600 mg twice daily with food during the 6-month run-in period in combination with androgen deprivation therapy. After randomization, darolutamide will be continued in both treatment groups according to the assigned treatment strategy. Treatment may be interrupted or dose-reduced according to protocol-defined toxicity management rules.

  • Androgen Deprivation Therapy (ADT)

    Drug

    Androgen deprivation therapy will be maintained throughout study treatment in both groups. The method of androgen deprivation therapy will be selected by the investigator according to the participant's clinical condition and may include surgical castration or medical castration with a luteinizing hormone-releasing hormone agonist or antagonist. Treatment will aim to maintain castrate testosterone levels according to the study protocol.

Treatment groups

254 Participants
are divided into 2 treatment groups
Group A: PSMA PET/CT-Guided SBRT + Darolutamide + ADTExperimental treatment 3 interventions
Group B: Darolutamide + ADTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

3-Year Radiographic Progression-Free Survival (rPFS)

Radiographic progression-free survival (rPFS) is defined as the time from randomization to radiographic disease progression or death from any cause, whichever occurs first. Progression is assessed using RECIST 1.1 for soft tissue and PCWG3 criteria for bone lesions. The 3-year rPFS rate will be estimated using the Kaplan-Meier method.

Time frame
From randomization to 3 years after randomization

Secondary outcomes

1

Overall Radiographic Progression-Free Survival (o-rPFS)

Overall radiographic progression-free survival is defined as the time from the first dose of induction therapy with darolutamide plus androgen deprivation therapy to the first occurrence of radiographic disease progression or death from any cause, whichever occurs first. Radiographic progression will be assessed according to RECIST 1.1 for soft-tissue lesions and PCWG3 criteria for bone lesions.

Time frame
From first dose of induction therapy to radiographic progression or death, assessed up to 60 months
2

PSA Progression-Free Survival (PSA-PFS)

PSA progression-free survival is defined as the time from randomization to PSA progression per PCWG3 criteria or death from any cause, whichever occurs first. For participants with a PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL from the PSA nadir, confirmed by a second consecutive value obtained ≥3 weeks later. For participants without a PSA decline from baseline, PSA progression is defined as a ≥25% increase from baseline with an absolute increase of ≥2 ng/mL after 12 weeks of treatment.

Time frame
From randomization to PSA progression or death, assessed up to 60 months
3

Time to Castration-Resistant Prostate Cancer (CRPC)

Time to castration-resistant prostate cancer is defined as the time from randomization to the development of castration-resistant prostate cancer under castrate testosterone levels, defined as serum testosterone \<50 ng/dL or \<1.7 nmol/L. Castration-resistant prostate cancer is defined by biochemical progression, radiographic progression, or unequivocal clinical progression according to protocol-defined criteria.

Time frame
From randomization to development of castration-resistant prostate cancer, assessed up to 60 months
4

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause.

Time frame
From randomization to death from any cause, assessed up to 60 months

Other outcomes

Sponsors and contacts

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

West China Hospital

Lead sponsor

Bayer

Collaborator

Source ClinicalTrials.gov

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