NCT07393867 Androgen-responsive POSLUMA-guided Intra-prostatic Boost
| NCT ID | NCT07393867 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Martin T. King, MD, PhD |
| Condition | Intermediate Risk Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2026-04-29 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 23 participants in total. It began in 2026-04-29 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT07393867 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Intermediate Risk Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07393867 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07393867 currently recruiting?
Yes, NCT07393867 is actively recruiting participants. Visit ClinicalTrials.gov or contact Martin T. King, MD, PhD to inquire about joining.
Where is the NCT07393867 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Milford, United States, Weymouth, United States.
Who is sponsoring the NCT07393867 clinical trial?
NCT07393867 is sponsored by Martin T. King, MD, PhD. The trial plans to enroll 23 participants.
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