Hormone Therapy for Prostate Cancer

Overseen By Rohan Garje, M.D.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Baptist Health South Florida

Must be taking: Androgen deprivation therapy

Disqualifiers: Renal impairment, Metastatic disease, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).

Who Is on the Research Team?

Rohan Garje, M.D.

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study.

Clinical laboratory values during screening: Hemoglobin ≥ 10.0 g/dL, Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹/L, Platelets ≥ 100 × 10⁹/L

I am a male and I am 18 years old or older.

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.

I have not had any cancers besides prostate, except cured skin cancer, in the past 5 years.

Any condition that, in the opinion of the investigator, would preclude participation in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant androgen deprivation therapy (ADT) for 6 months, with PET scans at baseline and after treatment

6 months

Multiple visits for ADT administration and PET scans

Radical Prostatectomy

Participants undergo radical prostatectomy after completion of ADT and PET scans

1 day (procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PSA response and biochemical recurrence-free survival

48 months

Regular follow-up visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Degarelix
• Leuprolide
• Relugolix
• Triptorelin

How Is the Trial Designed?

Group I: Neoadjuvant androgen deprivation therapy (ADT) followed by radical prostatectomy (RP) Experimental Treatment 7 Interventions

Participants will be prescribed one of four ADTs, administered over two treatment cycles spaced three months apart. * Leuprolide: Administered by a Health Care Practitioner (HCP), injecting the drug into the muscle every 3 months for 6 months total. * Degarelix: Administered by a HCP, injecting the drug under your skin every 28 days for 6 months. * Relugolix: Self-administered orally (pill), once daily for 6 months. * Triptorelin: Administered by a HCP, injecting the drug into the muscle every 3 months for 6 months total. Note: For those who receive leuprolide or triptorelin, bicalutamide also will be prescribed to take daily for 30 days starting from Day 1 of receiving leuprolide or triptorelin. All participants will receive a PET using 18F-flotufolastat at baseline and after 6 months of treatment with ADT. All participants will receive radical prostatectomy after the second 18F-flotufolastat PET scan.

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+