Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer

Official title

ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions

Overview

This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.

Detailed description

PRIMARY OBJECTIVE:

I. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains.

SECONDARY OBJECTIVES:

I. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains.

II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

III. To assess and compare patient-reported financial toxicities, using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) assessment tool.

IV. To assess and compare late physician-reported grade ≥ 2 GI and/or GU toxicities of interest within 24 months after SABR using the CTCAE v5.0.

V. To assess and compare change in International Index of Erectile Function (IIEF-15) and International Prostate Symptom Score (IPSS).

VI. To explore the association of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity.

VII. To explore the association of bladder filling on dosimetry, PROs, and toxicity.

VIII. To assess and compare the cumulative incidence of biochemical failure, local progression, distant metastasis, and metastasis-free survival within 60 months after SABR.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo near margin-less adaptive radiation therapy (ART) for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo cone beam computed tomography (CBCT) and may undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study.

ARM II: Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.

After completion of study treatment, patients are followed up at months 1, 3, and 6, and then every 6 months for up to 60 months.

Interventions

• Procedure Computed Tomography
  Undergo CT
• Procedure Cone-Beam Computed Tomography
  Undergo CBCT
• Radiation Image-Guided Adaptive Radiation Therapy
  Undergo near margin-less ART
• Procedure Magnetic Resonance Imaging
  Undergo MRI
• Procedure Stereotactic Ablative Radiotherapy
  Undergo standard SABR
• Other Survey Administration
  Ancillary studies

Primary outcome measures

• Treatment-related, patient-reported early quality of life (QOL) changes [Time frame: Baseline; up to 3 months]

Secondary outcome measures (11)

• Treatment-related, patient-reported late QOL changes [Time frame: Baseline; up to 24 months]
• Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events [Time frame: Up to 24 months]
• Change in International Index of Erectile Function (IIEF) [Time frame: Baseline; up to 24 months]
• Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline; up to 24 months]
• Change in financial adverse events - COST-FACIT [Time frame: Baseline; 12 months]
• Fiducial-free treatment [Time frame: Up to 5 years]
• Bladder filling [Time frame: Up to 5 years]
• Biochemical recurrence [Time frame: At 2 and 5 years]
• Prostate specific antigen (PSA) kinetics [Time frame: Up to 5 years]
• Local recurrence [Time frame: Up to 5 years]
• Overall survival [Time frame: From the date of registration to the date of death from any cause, assessed up to 5 years]

Eligibility criteria

Inclusion criteria

• Gender assigned male at birth: age ≥ 18 years
• Histological confirmation of prostate adenocarcinoma
• National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Ability to complete questionnaire(s) by themselves or with assistance
• Signed informed consent
• Willing to complete requirements for follow-up (during active monitoring phase)

Exclusion criteria

• NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
• Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
• Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
• Metastatic disease by conventional or molecular imaging
• Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
• Concurrent antineoplastic agents (chemotherapy)
• Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
• Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
• Prostate gland volume \> 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score \> 17
• Body weight \> 200 kilogram
• Known allergy or sensitivity to polyethylene glycol (PEG) or iodine

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 5 centers

• Mayo Clinic Health System in Albert Lea — Albert Lea
• Mayo Clinic Health System-Mankato — Mankato
• Mayo Clinic in Rochester — Rochester
• Mayo Clinic Health System-Eau Claire — Eau Claire
• Mayo Clinic Health System-Franciscan Healthcare — La Crosse

Identifiers

NCT: NCT06325046 · GMROR2351 · 23-003388

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗