Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Both arms will receive prostate radiation. Multiple treatment regimens are allowed per protocol.

Prostate radiation (XRT)

All systemic therapy is provided as best prescribed for patient per their medical oncologist.

Systemic Therapy

SABR is delivered to those randomized to Arm 2.

Stereotactic ablative radiation therapy (SABR)

Phuoc Tran, MD

Nicole Helie

Lalicia Roman

Caitlin Eggleston

Pilar Strycula, RN, BSN

This research is being done to determine if we can improve the outcome of prostate cancer patients who have failed primary treatment - surgery or local radiation to the prostate - and have three or fewer bone or soft tissue metastases.

This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.

TERPS Trial for de Novo Oligometastic Prostate Cancer

Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial

Cross-over to the SABR MDT is allowed following failure.

Adverse events will be assessed at baseline, on treatment visit, and follow-up visit.

Progression will be assessed for time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival and duration of response after randomization to best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) metastasis-directed therapy (MDT).

EPIC quality of life tool will be used to assess quality of life following treatment. This survey will be completed at baseline and during follow-up visits. Averages will be taken for each section in the survey (Urinary Function, Bowel Function, Sexual Function, and Hormonal function).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TERPS Trial for de Novo Oligometastic Prostate Cancer	NCT05223803	Prostate Cancer Oligometastatic...	Prostate radiat... Systemic Therap... Stereotactic ab...	18 Years -	University of Maryland, Baltimore
TERPS Trial for de Novo Oligometastic Prostate Cancer	NCT05223803	Prostate Cancer Oligometastatic...	Prostate radiat... Systemic Therap... Stereotactic ab...	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for prostate radiation (xrt)