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New treatment option for Intermediate Risk Prostate Cancer
Official title Androgen-responsive POSLUMA-guided Intra-prostatic Boost
ClinicalTrials.gov ID: NCT07393867
What this study is testing
What is Androgen Deprivation Therapy (ADT) +/- bicalutamide?
Androgen Deprivation Therapy (ADT) +/- bicalutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for intermediate risk 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
- This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment.
- 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 18 and older, men only
You may be able to join if
- 18 years of age and older.
- Eastern Oncology Group Status 0 to 1.
- Histologic diagnosis of prostate cancer.
- Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
- NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
You likely can't join if
- Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
- Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
- Clinical T4 disease.
- Prior ADT.
- Prior pelvic RT.
- Prior prostate surgery, including TURP.
See the full eligibility criteria
- 18 years of age and older.
- Eastern Oncology Group Status 0 to 1.
- Histologic diagnosis of prostate cancer.
- Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
- NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
- Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.
- Intention for SBRT (36.25 Gy/5 fraction) with focal boost (up to 50 Gy) to one MRI/PET-concordant lesion34.
- Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
- Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
- Clinical T4 disease.
- Prior ADT.
- Prior pelvic RT.
- Prior prostate surgery, including TURP.
- International prostate symptom score \> 20.
- Prior urethral stricture.
- Prostate volume \> 80 cc on MRI.
- Hip implants that cause artifacts over the prostate gland.
- Inability to discontinue anti-coagulation for fiducial marker placement.
- Active Crohn's disease or scleroderma.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Milford, Massachusetts, United States
- Weymouth, Massachusetts, 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 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Milford, Massachusetts, United States; Weymouth, Massachusetts, 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.