Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial

Sponsors

Lead Sponsor: Changhai Hospital

Source Changhai Hospital
Brief Summary

The aim of this study is to test the safety and feasibility of SBRT without ADT in oligometastatic prostate cancer in patients for whom the standard treatment is ADT, and to further explore how long only radiotherapy for oligometastases can prolong biochemical progression-free survival (bPFS). In this study, men with oligometastatic prostate cancer lesions will be randomized (1:1) to ADT versus SBRT. Within 6 weeks of the oligometastases diagnosis, ADT or SBRT (30-50Gy with 3-5 fractions) will be administered.

Detailed Description

The oligometastatic disease state is an increasingly recognized phenomenon in prostate cancer. Ga-68 PSMA PET/CT has high accuracy in the diagnosis metastases from prostate cancer. In this protocol, pretreatment Ga-68 PSMA PET/ CT shall be performed in all patients. ADT is considered standard of care treatment for advanced prostate cancer. But hormonal therapy can have side effects that greatly trouble men and lead to castration-resistant prostate cancer (CRPC). Any effort to delay the start of hormonal therapy would be an advantage to the patient. Stereotactic body radiation therapy (SBRT) is highly focused radiation, given in a very dose intensive fashion and delivered in usually less than one week. SBRT has been shown to be very effective on bone or lymph nodes metastases. Therefore, we are studying the safety and feasibility of SBRT on patients with five or fewer prostate cancer bone or lymph nodes metastases to determine if we can stall the use of hormonal therapy and/or prevent other site metastases from developing elsewhere in the body.

Overall Status Recruiting
Start Date November 11, 2020
Completion Date October 1, 2025
Primary Completion Date November 11, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
1-year ADT-free survival of the experimental group Assessment ADT-free survival of the experimental group at 1 year
The Probability of Radiotherapy-related Toxicity Assessment Toxicity at 1 year
The time from inception of the study to castration-resistant prostate cancer (CRPC) Assessment at 1 year
Secondary Outcome
Measure Time Frame
1-year Efficacy Biochemical Progression-free Survival (bPFS) 1 year
1-year Local Progression-Free-Survival(LPFS) Assessment at 1 year
1-year Distant Metastasis Free Survival(DMFS) Assessment at 1 year
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: ADT

Description: On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.

Arm Group Label: ADT

Intervention Type: Radiation

Intervention Name: SBRT

Description: Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).

Arm Group Label: SBRT

Eligibility

Criteria:

Inclusion Criteria: - 80 years old - Histologically confirmed adenocarcinoma of the prostate - Prostate cancer treated with curative intent (radical prostatectomy, primary radiotherapy, or a combination of both) - Ga-68 prostate-specific membrane antigen (PSMA) PET/CT evidence of one to three metastases (bone or lymph node) within 6 weeks of enrolment, if the position of oligometastases is judged by the doctor to be in the same radiotherapy area, the number of metastases can be appropriately increased to 5 - Without ADT treatment - PSA< 50ng/ml - ECOG performance status 0-2 - Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures Exclusion Criteria: - Any previous or ongoing treatment of oligometastases including radiotherapy, ADT, chemotherapy, focal treatment, etc. - Unstable lesions with spinal or long bone metastases - A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI - 4 metastases, or if the metastases are in the same radiotherapy area, ≥6 metastases - Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate - Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc. - Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc. - Patients who have participated in other clinical trials for less than three months - Unsuitable to participate in this clinical trial judged by the investigator

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Contact

Last Name: Huojun Zhang, PhD

Phone: 021-31162222

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Changhai hospital Huojun Zhang, M.D. 021-31162222 [email protected] Huojun Zhang, M.D. Principal Investigator
Location Countries

China

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Changhai Hospital

Investigator Full Name: Zhang Huo Jun

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: ADT

Type: Active Comparator

Description: Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.

Label: SBRT

Type: Experimental

Description: Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov