OncoMatch/Clinical Trials/NCT07325721
Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
Is NCT07325721 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for prostate cancer.
This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage LOCALIZED, III, N1M0 (NCCN)
Excluded: Stage METASTATIC DISEASE OUTSIDE OF THE PELVIC NODES
Grade: Gleason score 8-10grade group 4 or 5 (Gleason / grade group)
Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following: PSA >20 ng/mL prior to starting ADT; cT3a-T4 by digital exam or imaging; Gleason score of 8-10 (grade group 4 or 5); Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: cytotoxic chemotherapy
Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy)
Cannot have received: cryotherapy
Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy)
Cannot have received: ablative treatment
Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy)
Cannot have received: surgical therapy
Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy)
Cannot have received: radiation therapy
Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy)
Cannot have received: pelvic radiotherapy
Prior pelvic radiotherapy [excluded]
Cannot have received: total prostatectomy
Prior total prostatectomy [excluded]
Cannot have received: cryotherapy
Prior cryotherapy [excluded]
Cannot have received: high-intensity focused ultrasound
Prior high-intensity focused ultrasound [excluded]
Cannot have received: irreversible electroporation
Prior irreversible electroporation [excluded]
Cannot have received: MRI ablation
Prior MRI ablation [excluded]
Cannot have received: laser ablation
Prior laser ablation [excluded]
Cannot have received: transurethral ultrasound ablation
Prior transurethral ultrasound ablation [excluded]
Cannot have received: aquablation
Prior aquablation directed towards the prostate [excluded]
Cannot have received: investigational prostate cancer therapy
Treatment with another investigational prostate cancer therapy within 12 months [excluded]
Lab requirements
Blood counts
hemoglobin >=9.0 g/dL independent of transfusion; platelet count >= 100,000 x 10^9/microliter independent of transfusion
Liver function
total bilirubin <2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should be <2.4.
Adequate hematologic function within 120 days prior to registration as defined by: hemoglobin >=9.0 g/dL independent of transfusion, and platelet count >= 100,000 x 10^9/microliter independent of transfusion. Adequate hepatic function within 120 days prior to registration defined as total bilirubin <2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should be <2.4.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Medical University of South Carolina Hollings Cancer Center · Charleston, South Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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