SBRT for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience

• Sponsor: Kantonsspital Graubuenden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03604211
• Collaborator: Swiss Group for Clinical Cancer Research (Other)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 101.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Recurrent; Prostate Cancer; Lymph Node Metastases	Radiation: Cyberknife Radiation Therapy

Detailed Description

Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015.

Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors.

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2018

Outcome Measures

Primary Outcome Measures

1. time to biochemical recurrence [18 months]

   time interval from SBRT until second PSA rise

Secondary Outcome Measures

1. biochemical response rate [18 months]

   reduction by at least 10% of the initial PSA value

2. time interval between SBRT and ADT start [18 months]

   time interval between SBRT and ADT start

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male

Inclusion Criteria:

• histologically proven diagnosis of prostate cancer

• Radical prostatectomy (± salvage radiotherapy)

• PSA relapse (defined by two consecutive rising PSA values >0.2 ug/l)

• one to three lymphnodes positive on Choline-PET

• no recurrence in prostatic bed on Choline-PET

• WHO performance status of 0-1

• no previous chemotherapy or ADT for prostate cancer.

Exclusion Criteria:

• primary treatment for prostate cancer by RT or brachytherapy

• bone (M1b) metastases

• visceral (M1c) metastases

• any symptomatic nodal lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juergen Curschmann	Zürich		Switzerland	8032

Sponsors and Collaborators

• Kantonsspital Graubuenden
• Swiss Group for Clinical Cancer Research

Investigators

• Study Director: Daniel R Zwahlen, MD, Kantonsspital Graubuenden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kantonsspital Graubuenden
• ClinicalTrials.gov Identifier: NCT03604211
• Other Study ID Numbers: KGraubuenden
• First Posted: Jul 27, 2018
• Last Update Posted: Aug 17, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Lymphatic Metastasis; Recurrence

Study Results

No Results Posted as of Aug 17, 2018