A Study to Evaluate Hypofractionated Proton Therapy or IMRT for Recurrent, Oligometastatic Prostate Cancer

Overview

About this study

The purpose of this study is to assess late > grade 3 GI and/or GU toxicity of interest with the hypofractionated regimen with proton beam therapy or IMRT (late defined as 3 to 24 months after protocol RT).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Male participant.
Age ≥ 18 years old.
Histological confirmation of prostate adenocarcinoma.
Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate (can also include treatment of SVs and 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 PET/CT or other advanced PET imaging (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 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Brian Davis, M.D., Ph.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office (855) 776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brian Davis, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Clinical Trials