Recruiting
Phase 2

Radiation Treatment

Sponsor:

University of Rochester

Code:

NCT05946824

Conditions

Recurrent Prostate Cancer After Surgery

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Daily-adaptive Stereotactic Body Radiation Therapy

Daily-adaptive Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Recurrent Prostate Cancer After Surgery

Study ID

NCT05946824

Start date

Dec 14, 2023

Status verified date

Oct, 2024

Completion date

Nov 24, 2028

Anticipated

Primary completion date

Nov 24, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adenocarcinoma of the prostate with previous surgical resection
  • Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation
  • Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field
  • At least two serum detectable PSA levels defined as >0.02 ng/dl at least 30 days apart.

Exclusion Criteria:

  • Metastatic disease
  • Prior radiation therapy to the pelvis region
  • Inflammatory bowel disease
  • Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months
  • Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months
  • PSA >10 ng/dl at study entry,

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Daily-adaptive Stereotactic Body Radiation Therapy

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

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

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) [ Time Frame: 1-2 years ]
  • The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS). [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Michael Cummings, MD

585-275-5622michael_cummings@urmc.rochester.edu

Locations

Wilmot Cancer Institute - Dept of Radiation Oncology

Recruiting

Rochester, New York, United States, 14624

Contacts

Michael Cummings, MD

585-275-5622michael_cummings@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Keywords

  • Stereotactic body radiation therapy
  • daily-adaptive radiation therapy
  • prostate cancer
  • recurrent prostate cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2024-10-08.