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Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

Primary Purpose

Treatment

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

ADT

SBRT

About this trial

This is an interventional treatment trial for Treatment focused on measuring SBRT, Oligometastatic Prostate Cancer, Feasibility

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Changhai hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ADT

SBRT

Arm Description

Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.

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

Outcomes

Primary Outcome Measures

1-year ADT-free survival of the experimental group

To assess ADT-free survival of the experimental group

The Probability of Radiotherapy-related Toxicity

Radiotherapy-related complications

The time from inception of the study to castration-resistant prostate cancer (CRPC)

the time from inception of the study to castration-resistant prostate cancer (CRPC)

Secondary Outcome Measures

1-year Efficacy Biochemical Progression-free Survival (bPFS)

Biochemical Progression-free Survival (bPFS)

1-year Local Progression-Free-Survival(LPFS)

Local Progression-Free-Survival(LPFS)

1-year Distant Metastasis Free Survival(DMFS)

Distant Metastasis Free Survival(DMFS)

Full Information

NCT ID

NCT04599686

First Posted

October 10, 2020

Last Updated

August 9, 2022

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04599686

Brief Title

Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 11, 2022 (Anticipated)

Primary Completion Date

November 11, 2022 (Anticipated)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment

Keywords

SBRT, Oligometastatic Prostate Cancer, Feasibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ADT

Arm Type

Active Comparator

Arm Description

Evaluating men with oligometastatic prostate cancer lesions randomized to ADT.

Arm Title

SBRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ADT

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

SBRT

Intervention Description

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

Primary Outcome Measure Information:

Title

1-year ADT-free survival of the experimental group

Description

To assess ADT-free survival of the experimental group

Time Frame

Assessment ADT-free survival of the experimental group at 1 year

Title

The Probability of Radiotherapy-related Toxicity

Description

Radiotherapy-related complications

Time Frame

Assessment Toxicity at 1 year

Title

The time from inception of the study to castration-resistant prostate cancer (CRPC)

Description

the time from inception of the study to castration-resistant prostate cancer (CRPC)

Time Frame

Assessment at 1 year

Secondary Outcome Measure Information:

Title

1-year Efficacy Biochemical Progression-free Survival (bPFS)

Description

Biochemical Progression-free Survival (bPFS)

Time Frame

1 year

Title

1-year Local Progression-Free-Survival(LPFS)

Description

Local Progression-Free-Survival(LPFS)

Time Frame

Assessment at 1 year

Title

1-year Distant Metastasis Free Survival(DMFS)

Description

Distant Metastasis Free Survival(DMFS)

Time Frame

Assessment at 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huojun Zhang, PhD

Phone

021-31162222

chyyzhj@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xianzhi Zhao, MD

Phone

021-31162222

zhxzh0007@163.com

Facility Information:

Facility Name

Changhai hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huojun Zhang, M.D.

Phone

021-31162222

chyyzhj@163.com

First Name & Middle Initial & Last Name & Degree

Huojun Zhang, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data including baseline characteristics,treatment information and follow-up data on toxicity, survival and disease control will be shared.

IPD Sharing Time Frame

Within 5 years after the publication of the study.

IPD Sharing Access Criteria

Data may be shared with radiation oncologists who are interested in examining the efficacy and toxicity of oligometastatic prostate cancer treated with stereotactic body radiotherapy (SBRT) or androgen deprivation therapy (ADT). Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

IPD Sharing URL

http://clinicaltrials.gov/ct2/show/NCT04599686?term=NCT04599686&draw=2&rank=1

Citations:

PubMed Identifier

36180115

Citation

Zhao X, Wang T, Ye Y, Li J, Gao X, Zhang H. Stereotactic body radiotherapy (SBRT) versus androgen deprivation therapy (ADT) for oligometastatic prostate cancer: protocol for a prospective randomised control clinical trial. BMJ Open. 2022 Sep 30;12(9):e051371. doi: 10.1136/bmjopen-2021-051371.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://clinicaltrials.gov/ct2/results?cond=&term=NCT04599686&cntry=&state=&city=&dist=

Available IPD/Information Identifier

NCT04599686

Available IPD/Information Comments

Please see the clinical trials NCT04599686

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Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer

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