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NCT Number: NCT05946824

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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Wilmot Cancer Institute - Dept of Radiation Oncology

Rochester, New York, 14624, United States

Location status: Recruiting

Location contact

Michael Cummings, MD

CONTACT

[email protected]

585-275-5622

Michael Cummings, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

    Time frame: 1-2 years

    The Primary objective of the safety lead in component is to report acute, attributable genitourinary and gastrointestinal toxicity as scored by CTCAE v5.0.

  2. The primary objective of the full enrollment Phase II component is to report biochemical recurrence free survival (bPFS).

    Time frame: 5 years

    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.

Secondary outcomes

  1. Long term side effects

    Time frame: 5 years

    Late patient toxicity as defined by EPIC-IPSS prostate QoL forms

  2. Distant metastasis free survival

    Time frame: 5 years

    Development of metastatic prostate cancer to other parts of the body

  3. Need for long term anti-testosterone therapy

    Time frame: 5 years

    Time to initiation of non-protocol hormonal therapy, if needed

Other outcomes

  1. Planning parameters and techniques

    Time frame: 5 years

    Identification of novel artificial-intelligence aided planning techniques, algorithms, and utilization as uncovered during the course of therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Cummings, MD

CONTACT

[email protected]

585-275-5622

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Varian Medical Systems

Registry information

Official study title

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

Acronym: DASBRT-RPC

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Jul 14, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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