This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.

Conditions

• Recurrent Prostate Cancer After Surgery

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Daily-adaptive Stereotactic Body Radiation Therapy — RADIATION
  Daily-adaptive radiation therapy to two dose levels - one to the area of radiologic recurrent nodal disease, and a lower, prophylactic dose to the standard post-prostatectomy and larger pelvic node fields
• Daily-adaptive Stereotactic Body Radiation Therapy — RADIATION
  Daily-adaptive radiation therapy to two areas - a high dose to the area of radiologic recurrence, and a lower, prophylactic dose to the standard post-prostatectomy fields

Study Details

There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.

Key Dates

Start date

Dec 14, 2023

Status verified

Oct 2024

Primary completion

Nov 24, 2025

Completion

Nov 24, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1 - Prostate bed only recurrence
  Patients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.
• Experimental: 2- Pelvic nodal with or without a prostate bed recurrence
  Patients who have a radiologic recurrence of prostate cancer in the pelvic node region

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) [ Time Frame: 1-2 years ]

Central Contacts

• Michael Cummings, MD
  585-275-5622
  [email protected]

Locations (1)

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