Trial NCT07393867
Androgen-responsive POSLUMA-guided Intra-prostatic Boost
- Phase
- Phase 2
- Sponsor
- Martin T. King, MD, PhD
- Conditions
- Intermediate Risk Prostate Cancer; High Risk Prostate Cancer; Prostate Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* 18 years of age and older.
* Eastern Oncology Group Status 0 to 1.Performance status
* 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.
Restrictions found (1)
- Performance statusConditionalinclusion
ECOG 0 to 1
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Recruiting in Massachusetts
- Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center · Milford, Worcester County
- Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital · Weymouth, Norfolk County