Stereotactic Body Radiation for Prostate Oligometastases

NCT02680587 | Completed Phase 2 Results DMC

• 2 other identifiers: J15180IRB00079078
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Oligometastases

Keywords

Prostate Cancer; Stereotactic Body Radiation Therapy; Stereotactic Ablative Radiotherapy; Oligometastasis

Outcome Measures

Primary Outcomes (1)

• Progression at 6 Months

  Number of participants who progressed at 6 months. Progression is defined as either: 1) a ≥ 25% increase in PSA from nadir (and by ≥ 2 ng/mL), requiring confirmation ≥ 4 weeks later (PCWG2 criteria); and/or, 2) clinical/radiographic-progression defined as symptomatic progression (worsening disease-related symptoms or new cancer-related complications), or radiologic progression (on CT scan: ≥ 20% enlargement in sum diameter of soft-tissue target lesions \[RECIST1.1 criteria\]; on bone scan: ≥ 1 new bone lesions),initiation of ADT or death due to any cause, whichever occurs first.

  6 months

Secondary Outcomes (8)

• Time to Local Progression

  up to 6 months

• Local Control of SBRT Group

  6 months

• Toxicity as Assessed by Number of Participants With Adverse Events Grade 3 or Higher

  up to 6 months

• Toxicity as Assessed by Number of Participants With Adverse Events Grades 1 or 2

  up to 6 months

• Change in Quality of Life as Assessed by Brief Pain Inventory

  Baseline and 6 months

Study Arms (2)

Observational (no SBRT)

NO INTERVENTION

Men with oligometastatic prostate cancer lesions randomized to observation

SBRT

EXPERIMENTAL

Men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).

Radiation: SBRT

Interventions

SBRT RADIATION

SBRT (1-5 fractions) will be administered.

Also known as: Stereotactic Body Radiation, Stereotactic Ablative Radiotherapy

SBRT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Phillips 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 BACKGROUND

• Radwan 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 BACKGROUND

• Marvaso 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 DERIVED

• Deek 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 DERIVED

Related Links

• Gleason Score Description

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Phuoc T. Tran
• Organization: Johns Hopkins University

ptran12@jhmi.edu

4106143880

Study Officials

• Phuoc Tran, M.D.

  Johns Hopkins Department of Radiation Oncology and Molecular Radiation Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 11, 2016
• Study Start: April 28, 2016
• Primary Completion: August 30, 2018
• Study Completion: October 31, 2022
• Last Updated: November 29, 2022
• Results First Posted: December 22, 2021

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)