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

Summary

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

Inclusion Criteria:

1. Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
2. Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
3. Subjects must have one of the following risk factors:

   * PSA ≥20 and/or
   * Gleason score ≥8 and/or
   * Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or
   * At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 4+3, clinical stage = T2b/T2c, ≥50% positive biopsy cores.
4. Subjects must freely sign informed consent to enroll in the study.
5. Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI.
6. Age ≥ 40
7. ECOG Performance Status (performance status is an attempt to quantify cancer patients\' general well-being and activities of daily life, scores range from 0 to 5 where 0 represents perfect health and 5 represents death): 0-1.
8. No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible.
9. Subjects must not have had prior androgen deprivation therapy in the past 6 months.

Exclusion Criteria:

1. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
2. Declared high-risk for anesthesia by attending cardiologist, or other physician.
3. History of prior pelvic radiation therapy.
4. Prostate gland \>70 cc as assessed by MRI or TRUS.
5. Baseline IPSS \>15 with medical optimization.
6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
7. Unwilling or unable to comply with the study protocol.

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Conditions2

Locations1 site

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