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Compares treatment options for Prostate Cancer
Official title ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
ClinicalTrials.gov ID: NCT06397703
What this study is testing
What is Leuprolide, Degarelix or Relugolix?
Leuprolide, Degarelix or Relugolix is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
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
- For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease...
- Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
- Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
- At least 4 weeks must have elapsed from major surgery
- Karnofsky Performance Scale (KPS) ≥ 80%
You likely can't join if
- CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer...
- History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer...
- Patients with Crohn's disease or ulcerative colitis
See the full eligibility criteria
- Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores \> 50% of Gleason 7 disease; 2-3 intermediate...
- Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
- Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
- At least 4 weeks must have elapsed from major surgery
- Karnofsky Performance Scale (KPS) ≥ 80%
- Prostate size as determined on MRI to be \< 90 cc. Prostate size can be determined on CT scan if MRI is not available
- IPSS ≤ 20
- Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable
- Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to...
- Adequate renal function with serum creatinine less than or equal to 1.5 x ULN
- Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value \> 9 g/dL (Note: patients whose anemia has been corrected to a...
- CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone
- Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or...
- History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other...
- Patients with Crohn's disease or ulcerative colitis
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.