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.

Trial Title: 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.

NCT ID: NCT05946824

Condition: Recurrent Prostate Cancer After Surgery

Conditions: Official terms:
Prostatic Neoplasms
Recurrence

Conditions: Keywords:
Stereotactic body radiation therapy
daily-adaptive radiation therapy
prostate cancer
recurrent prostate cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: This will be a two cohort Phase II single center, prospective trial, with a safety lead-in component. The cohorts will be defined by location of recurrence - either prostate bed alone, or a pelvic node with or without a prostate bed recurrence. This design will allow an initial toxicity assessment phase of a novel radiation treatment schema that is based on other literature, but with limited evidence. There is no plan to escalate the dose. Pending assessment of the safety lead in, complete enrollment will be permitted. Each cohort will be analyzed separated for the safety lead in.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Daily-adaptive Stereotactic Body Radiation Therapy
Description: 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
Arm group label: 1 - Prostate bed only recurrence

Intervention type: Radiation
Intervention name: Daily-adaptive Stereotactic Body Radiation Therapy
Description: 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
Arm group label: 2- Pelvic nodal with or without a prostate bed recurrence

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.

Detailed description: This will be a two cohort Phase II single center, prospective trial, with a safety lead-in component. This design will allow an initial toxicity assessment phase of a novel radiation treatment schema that is based on other literature, but with limited evidence. There is no plan to escalate the dose. Pending assessment of the safety lead in, complete enrollment will be permitted. Each cohort will be analyzed separated for the safety lead in. There will be 7 patients in the safety lead in cohorts. The stopping point will be an incidence of 2 cases of CTCAE v5.0 Grade 3+ acute toxicity attributed to therapy within gastrointestinal or urinary domains. This generally entails symptoms significant enough to require a procedure or limit basic levels of daily activity (bathing, cooking). Actue toxicity of a comparable magnitude has been reported in the 1-5% rate in a recent meta-analysis of contemporary trials which utilized standard of care radiation. Thus two cases would represent an unacceptable increased toxicity level, and a cohort size of 7 is approximate the commonly accepted size in Phase I escalation studies to evaluate dose limiting toxicity.

Criteria for eligibility:
Criteria:
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,

Gender: Male

Gender based: Yes

Gender description: Patients must have prostate cancer to be eligible

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Wilmot Cancer Institute - Dept of Radiation Oncology

Address:
City: Rochester
Zip: 14624
Country: United States

Status: Recruiting

Contact:
Last name: Michael Cummings, MD

Phone: 585-275-5622
Email: michael_cummings@urmc.rochester.edu

Contact backup:
Last name: Michael Cummings, MD

Start date: December 14, 2023

Completion date: November 24, 2028

Lead sponsor:
Agency: University of Rochester
Agency class: Other

Collaborator:
Agency: Varian Medical Systems
Agency class: Industry

Source: University of Rochester

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05946824