Stereotactic Body Radiation for Prostate Oligometastases

Men with oligometastatic prostate cancer lesions will be randomized (1:2) to observation versus SBRT. The study will NOT be blinded. Within three weeks of the initial treatment planning, SBRT (1-5 fractions) will be administered.

Sex

Male

Minimum age

18 Years

Maximum age

100 Years

Inclusion Criteria:

* Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue develop within the past 6-months that are ≤ 5.0 cm or \<250 cm3.
* Patient must have had their primary tumor treated with surgery and/or radiation.
* Histologic confirmation of malignancy (primary or metastatic tumor).
* PSADT \<15 months. PSA doubling time (PSADT) will be calculated using as many PSA values that are available from time of relapse (PSA \> 0.2). To calculate PSADT, the Memorial Sloan Kettering Cancer Center Prostate Cancer

Prediction Tool will be used. It can be found at the following web site:

https://www.mskcc.org/nomograms/prostate/psa-doubling-time.

* Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed).
* PSA \>1 but \<50.
* Testosterone \> 125 ng/dL.
* Patient must have a life expectancy ≥ 12 months.
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patient must have normal organ and marrow function as defined as:

Leukocytes \>2,000/μL Absolute Neutrophil Count \>1,000/μL Platelets \>50,000/μL

\- Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred greater than 6 months prior to enrollment.
* DCFPyL-PET/MRI or DCFPyL-PET/CT scan within the past 6 months with results that demonstrate more disease lesions than baseline CT/Bone Scan
* Castration-resistant prostate cancer (CRPC).
* Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
* Patient receiving any other investigational agents.
* Patient is participating in a concurrent treatment protocol.
* Total bilirubin \> 3 times the upper limit of normal.
* Liver Transaminases \> 5-times the upper limit of normal.
* Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
* Liver Transaminases \> 5-times the upper limit of normal.
* Prior salvage treatment to the primary prostate cancer or pelvis is allowed.
* Refusal to sign informed consent.

• BACKGROUNDPhillips R, Shi WY, Deek M, Radwan N, Lim SJ, Antonarakis ES, Rowe SP, Ross AE, Gorin MA, Deville C, Greco SC, Wang H, Denmeade SR, Paller CJ, Dipasquale S, DeWeese TL, Song DY, Wang H, Carducci MA, Pienta KJ, Pomper MG, Dicker AP, Eisenberger MA, Alizadeh AA, Diehn M, Tran PT. Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):650-659. doi: 10.1001/jamaoncol.2020.0147. PMID 32215577
• BACKGROUNDRadwan N, Phillips R, Ross A, Rowe SP, Gorin MA, Antonarakis ES, Deville C, Greco S, Denmeade S, Paller C, Song DY, Diehn M, Wang H, Carducci M, Pienta KJ, Pomper MG, DeWeese TL, Dicker A, Eisenberger M, Tran PT. A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE). BMC Cancer. 2017 Jun 29;17(1):453. doi: 10.1186/s12885-017-3455-6. PMID 28662647
• DERIVEDMarvaso G, Corrao G, Zaffaroni M, Vincini MG, Lorubbio C, Gandini S, Fodor C, Netti S, Zerini D, Luzzago S, Mistretta FA, Venetis K, Cursano G, Burla T, Mazzocco K, Cattani F, Petralia G, Fusco N, Pravettoni G, Musi G, De Cobelli O, Tang C, Ost P, Palma DA, Orecchia R, Jereczek-Fossa BA. ADT with SBRT versus SBRT alone for hormone-sensitive oligorecurrent prostate cancer (RADIOSA): a randomised, open-label, phase 2 clinical trial. Lancet Oncol. 2025 Mar;26(3):300-311. doi: 10.1016/S1470-2045(24)00730-7. PMID 40049196
• DERIVEDDeek MP, Van der Eecken K, Sutera P, Deek RA, Fonteyne V, Mendes AA, Decaestecker K, Kiess AP, Lumen N, Phillips R, De Bruycker A, Mishra M, Rana Z, Molitoris J, Lambert B, Delrue L, Wang H, Lowe K, Verbeke S, Van Dorpe J, Bultijnck R, Villeirs G, De Man K, Ameye F, Song DY, DeWeese T, Paller CJ, Feng FY, Wyatt A, Pienta KJ, Diehn M, Bentzen SM, Joniau S, Vanhaverbeke F, De Meerleer G, Antonarakis ES, Lotan TL, Berlin A, Siva S, Ost P, Tran PT. Long-Term Outcomes and Genetic Predictors of Response to Metastasis-Directed Therapy Versus Observation in Oligometastatic Prostate Cancer: Analysis of STOMP and ORIOLE Trials. J Clin Oncol. 2022 Oct 10;40(29):3377-3382. doi: 10.1200/JCO.22.00644. Epub 2022 Aug 24. PMID 36001857