Prostate Cancer study: FTLEAD vs HypoLEAD
Official title The University of Miami Adapt (UAdapt) Trial
ClinicalTrials.gov ID: NCT06111313
What this study is testing
What is Ultra-Short-Term Androgen Deprivation Therapy with Relugolix?
An investigational hormone therapy being studied as a potential treatment for prostate cancer. Relugolix is designed to block the hormone signals that tell the prostate to grow by antagonizing the LHRH receptor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a single high-dose radiation session to the tumor, sometimes with short-term hormone therapy, can treat prostate cancer while keeping side effects low.
- Who it's for
- Men with early-stage or higher-risk prostate cancer.
- What's involved
- Participants receive one high-dose radiation session to the tumor. Some also get short-term hormone therapy or additional radiation sessions to the whole prostate, along with scans and biopsies.
- Time commitment
- The study involves multiple visits for radiation treatments, scans, and biopsies over several months.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 85, men only
You may be able to join if
- Biopsy confirmed adenocarcinoma of the prostate (including intraductal adenocarcinoma, excluding small cell carcinoma).
- T1-T3 disease based on digital rectal exam (DRE), informed by mpMRI.
- Patients with T3 disease based on DRE, mpMRI, Gleason 8-10, or a PSA of \>15 ng/mL, should undergo a negative metastatic workup prior to signing of...
- No evidence of metastasis by clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria).
- Gleason score 6-10.
You likely can't join if
- Prior pelvic radiotherapy.
- Prior androgen ablation therapy.
- Prior or planned radical prostate surgery.
- Clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease with the following specifications: PSMA-PET or Fluciclovine...
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell...
- Zubrod status \>2.
See the full eligibility criteria
- Biopsy confirmed adenocarcinoma of the prostate (including intraductal adenocarcinoma, excluding small cell carcinoma).
- T1-T3 disease based on digital rectal exam (DRE), informed by mpMRI. Prostate MRI may aid in the staging evaluation by verifying organ-confined status6,7.
- Patients with T3 disease based on DRE, mpMRI, Gleason 8-10, or a PSA of \>15 ng/mL, should undergo a negative metastatic workup prior to signing of consent.
- No evidence of metastasis by clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria).
- Gleason score 6-10.
- Prostate specific antigen (PSA) ≤100 ng/mL within (≤) 3 months of signing of consent. If PSA was above 100 ng/mL and drops to ≤100 ng/mL with antibiotics, this is acceptable for enrollment.
- Suspicious peripheral zone or central gland lesion(s) on mpMRI.
- Peripheral zone: Distinct lesion on dynamic contrast enhanced (DCE)-MRI with early enhancement and later washout (Note: contrast not required for enrollment), and/or distinct lesion on the apparent diffusion coefficient...
- Central gland: A suspicious central gland lesion on mpMRI must have a distinct lesion on the ADC map (Value \<1000).
- No previous pelvic radiotherapy.
- No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
- No concurrent, active malignancy, other than nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma).
- Ability to understand and the willingness to sign a written informed consent document.
- Zubrod performance status ≤2. Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod.
- Age ≥35 and ≤85 years at signing of consent.
- Serum testosterone is within 40% of normal assay limits (eg, x=0.4\ lower assay limit and x=0.4\ upper assay limit + upper assay limit), taken within (≤) 3 months of signing of consent.
- Anti-androgen therapy and ADT must be started after 3-week post-LEAD RT gradient biopsy.
- Anti-androgen therapy and ADT are recommended to be started prior to or concurrent with start of moderately hypofractionated RT course and must be started before the end of the hypofractionated RT course.
- The total length planned must be ≤ 30 months.
- Patient unable to receive iodine or gadolinium contrast due to allergy or poor renal function are still eligible for enrollment.
- Prior pelvic radiotherapy.
- Prior androgen ablation therapy.
- Prior or planned radical prostate surgery.
- Clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease with the following specifications: PSMA-PET or Fluciclovine PET: Patients with subclinical (\<1.5 cm) pelvic lymph nodes that are...
- Concurrent, active malignancy, other than nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma).
- Zubrod status \>2.
- Pretreatment PSA \>100 ng/ml or Gleason score \<6. If PSA was above 100 ng/mL and drops to ≤100 ng/mL with antibiotics, this is acceptable for enrollment.
- Thyroxine (T4) disease.
- Patients with impaired decision-making capacity who lack the ability to understand and voluntarily sign a written informed consent document.
- Patients unable to tolerate diagnostic MRI acquisition. Note: inability to tolerate contrast agents is not exclusionary.
The study team makes the final eligibility decision.
Where it is enrolling
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 35 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Miami, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.