Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorThe Methodist Hospital Research Institute

About this trial

This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients.

Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.

Eligibility criteria

Qualifiers

Subjects must have biopsy-confirmed adenocarcinoma of the prostate.

Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.

PSA ≥20 and/or

Gleason score ≥8 and/or

Disqualifiers

Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.

Declared high-risk for anesthesia by attending cardiologist, or other physician.

History of prior pelvic radiation therapy.

Prostate gland >70 cc as assessed by MRI or TRUS.

Trial design

Treatments tested in this trial

  • Brachytherapy

Treatment groups

29 Participants
are divided into 2 treatment groups