Prostate Cancer Clinical Trial

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

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.

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Full 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.

ARM II: Patients undergo IMRT 5 days a week over 5 weeks.

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT04190446

Recruitment Status:

Suspended

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

83

Study ID:

NCT04190446

Recruitment Status:

Suspended

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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