Radiation Therapy (Hypofractionated Proton Beam Therapy or IMRT) for the Treatment of Recurrent, Oligometastatic Prostate Cancer Following Primary Localized Treatment

Prostate Adenocarcinoma Clinical Trial

Official title:

A Randomized, Parallel Phase II Trial of Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer Involving Only Pelvic and/or Para-Aortic Lymph Nodes Following Primary Localized Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04190446
• Other study ID #: MC1851
• Secondary ID: NCI-2019-07705MC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 6, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies the side effects of radiation therapy (hypofractionated proton beam therapy or IMRT) for the treatment of prostate cancer that has come back (recurrent) or that has spread to a limited number of sites (oligometastatic) following primary localized treatment. Hypofractionated proton beam radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. IMRT uses high energy x-rays to kill tumor cells and shrink tumors. This trial is being done to find out if a shorter course of radiation therapy is better with fewer side effects for patients with recurrent prostate cancer.

Description:

PRIMARY OBJECTIVE:

I. To assess late >= grade 3 gastrointestinal (GI) and/or genitourinary (GU) toxicity of interest with the hypofractionated regimen with proton beam therapy or intensity-modulated radiation therapy (IMRT) (late defined as 3 to 24 months after protocol radiation therapy [RT]).

SECONDARY OBJECTIVES:

I. Late grade >= 2 GI and/or GU toxicities of interest within 24 months after the protocol RT, using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0.

II. Acute grade >= 3 GI and/or GU toxicities of interest during and within 3 months after the protocol RT, using the CTCAE v4.0.

III. Compare the rates of late >= grade 3 GI and/or GU toxicity between the 2 treatment schedules.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo proton beam radiation therapy 5 days a week over 3 weeks. Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), and blood sample collection throughout the study.

ARM II: Patients undergo IMRT 5 days a week over 5 weeks. Patients undergo PET scan, CT scan, MRI, and blood sample collection throughout the study.

After completion of study, patients are followed up at 3-6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male; age >= 18 years

• Histological confirmation of prostate adenocarcinoma

• Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate (can also include treatment of splenic vessels [SVs] and lymph nodes [LNs]) or salvage RT to the prostate fossa (can also include prior pelvic RT)

• Oligometastatic extent of disease

• Recurrent disease involving lymph nodes as diagnosed with choline positron emission tomography (PET)/computed tomography (CT) or other advanced PET imaging (prostate-specific membrane antigen [PSMA] or flucyclovine)

• Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes

• Zubrod performance score (PS) =< 1

• Signed informed consent

Exclusion Criteria:

• Bone or visceral metastases present

• Lymph node metastases beyond the pelvis and/or retroperitoneum

• Contraindications to RT (e.g., uncontrolled inflammatory bowel disease)

• Contraindications to androgen suppression

• Concurrent antineoplastic agents (chemotherapy)

• Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer

• Inability to start the radiation portion of the protocol treatment within 6 months after study enrollment

• Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Metastatic Prostate Adenocarcinoma
• Oligometastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Recurrence
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer AJCC v8

Intervention

Radiation:
• Intensity-Modulated Radiation Therapy
Undergo IMRT
• Proton Beam Radiation Therapy
Undergo proton beam radiation therapy

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Computed Tomography
Undergo CT scan
• Magnetic Resonance Imaging
Undergo MRI
• Biospecimen Collection
Undergo blood sample collection

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expanded Prostate Cancer Index Composite short form (EPIC-26) questionnaire	Subdomains for urinary, bowel, and sexual function will be evaluated at each time point and summarized descriptively. Changes across time will be evaluated to assess patient function and quality of life after study treatment.	Up to 60 months
Other	Disease-free survival	The distribution of disease-free survival will be estimated using the method of Kaplan-Meier.	From registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause, assessed at 2 and 5 years
Other	Disease-specific survival	The distribution of disease-specific survival will be estimated using the method of Kaplan-Meier.	From registration until the date of death due to prostate cancer, assessed up to 2 and 5 years
Other	Overall survival	The distribution of overall survival will be estimated using the method of Kaplan-Meier.	From registration until the death due to any cause, assessed at 2 and 5 years
Primary	Proportion of patients who experience a late (>= 90 days after radiation therapy [RT] start date) grade 3 or higher gastrointestinal (GI) and/or genitourinary (GU) adverse event (AE)	Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. The proportion of grade 3 or higher GI or GU toxicities will be estimated by the number of patients with a late grade 3 or higher GI or GU toxicity divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the toxicity proportion will be calculated.	Up to 24 months after RT
Secondary	Incidence of acute adverse events	The rate of >= grade 3 GI or GU acute adverse events will be estimated by the number of patients with a >= grade 3 GI or GU acute adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 3 GI or GU acute adverse events will be calculated.	Up to 3 months after the completion of RT
Secondary	Incidence of late adverse events	The rate of >= grade 2 GI or GU late adverse events will be estimated by the number of patients with a >= grade 2 GI or GU late adverse event divided by the total number of evaluable patients. Exact binomial 90% confidence intervals for the true rate of >= grade 2 GI or GU late adverse events will be calculated.	Between 3 months and 2 years after completion of proton beam therapy
Secondary	Proportion of grade 3 or higher GI or GU adverse events	The difference between the 2 treatment arm proportions will be determined and exact binomial 90% confidence intervals for the difference in grade 3 or higher GI or GU toxicity rates will be calculated.	Up to 60 months
Secondary	Incidence of adverse events	All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s). The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Acute and late adverse events will be summarized separately.	Up to 60 months

External Links

•   Mayo Clinic Clinical Trials