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. (DASBRT-RPC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Prostate Cancer After Surgery
• Intervention / Treatment: Radiation: Daily-adaptive Stereotactic Body Radiation Therapy; Radiation: Daily-adaptive Stereotactic Body Radiation Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michael Cummings, MD; Phone Number: 585-275-5622; Email: michael_cummings@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14624
      • Recruiting
      • Wilmot Cancer Institute - Dept of Radiation Oncology
      • Contact: Michael Cummings, MD; Phone Number: 585-275-5622; Email: michael_cummings@urmc.rochester.edu
      • Contact: Michael Cummings, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])	The Primary objective of the safety lead in component is to report acute, attributable genitourinary and gastrointestinal toxicity as scored by CTCAE v5.0.	1-2 years
The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).	We will utilize a globally standard definition of bPFS which was defined in the RADICALS(6) international trial as follows: freedom from PSA of 0·4 ng/mL or greater following postoperative radiotherapy, or PSA of more than 2·0 ng/mL at any time following therapy, clinical progression, or initiation of non-protocol hormone therapy, or death from any cause.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term side effects	Late patient toxicity as defined by EPIC-IPSS prostate QoL forms	5 years
Distant metastasis free survival	Development of metastatic prostate cancer to other parts of the body	5 years
Need for long term anti-testosterone therapy	Time to initiation of non-protocol hormonal therapy, if needed	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Planning parameters and techniques	Identification of novel artificial-intelligence aided planning techniques, algorithms, and utilization as uncovered during the course of therapy	5 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Varian Medical Systems

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): November 24, 2025
• Study Completion (Estimated): November 24, 2028

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: recurrent prostate cancer; prostate cancer; Stereotactic body radiation therapy; daily-adaptive radiation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: URGUP22037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes