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.

Official title

Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy

Overview

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.

Interventions

• Radiation 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
• Radiation 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 measures

• 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]

Secondary outcome measures (3)

• Long term side effects [Time frame: 5 years]
• Distant metastasis free survival [Time frame: 5 years]
• Need for long term anti-testosterone therapy [Time frame: 5 years]

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Wilmot Cancer Institute - Dept of Radiation Oncology — Rochester

Identifiers

NCT: NCT05946824 · URGUP22037

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗