Prospective Evaluation of 68-Ga-prostate Specific Membran... | NCT02699424

Studies
Prospective Evaluation of 68-Ga-prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomograph (PET) and Early Prostatic Specific Antigen (PSA) Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy

NCT02699424

Sponsor

Lund University Hospital

Status

Completed

Last Update Posted

May 27, 2020Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Relapsed Prostate Cancer

Interventions

External radiation therapy

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2019Actual

First Submitted Date

Feb 11, 2016

First Submission Date that Met QC Criteria

Mar 3, 2016

First Posted Date

Mar 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2020

Last Update Posted Date

May 27, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy. Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on PSA response at fifth week of radiotherapy.

A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor PSA response. Patients with PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor PSA response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
Radiotherapy	Other		Radiation: External radiation therapy

Name	Type	Description	Arm Group Labels	Other Names
External radiation therapy	Radiation		Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tumor detection rate measured with Ga-PSMA-PET in non-responders versus responders.		PSA response is evaluated after 5 weeks of radiotherapy. Ga-PSMA-PET at baseline is compared in the PSA-responder group as compared to the non-responder group
Assessment of PSA response during radiotherapy.		Is evaluated once weekly during radiotherapy, duration of radiotherapy is 35 days; 70 Gy in 2 Gy fractions.

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Assessment of PSA response post treatment.		Is evaluated at 6, 12, 24, and 60 months post-treatment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histological evidence of prostate cancer in the radical prostatectomy specimen
At least 2 rising PSA values, of which the last ≥ 0.15 ng/ml
Tumor, regional nodes, metastasis (TNM): any T, N0/x, M0/x
Age: 18 years or older
World Health Organization (WHO) performance status 0-1
Life expectancy > 10 years
Adequate laboratory findings: hematological: hemoglobin > 90 g/L (may be transfused to maintain or exceed this level) absolute neutrophil count (ANC) ≥ 1,0 x 109/L, platelets ≥ 75 x 109/L hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN renal: creatinine ≤ 1.5 x ULN
Signed written informed consent
The patient must be able to comply with the protocol

Exclusion Criteria:

Evidence of metastasis on imaging or in specimen (e.g. N1 at lymph-node dissection)
Prior or ongoing treatment with hormones (antiandrogens, GnRH)
Prior radiotherapy to the pelvis
Previous malignancy other than prostate cancer and basalioma the past 5 years.
Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
Severe pulmonary disease e.g. pulmonary fibrosis
Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Adalsteinn Gunnlaugsson, MD, PhD	Lund University Hospital, Department of Oncology	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Lund University Hospital		Lund		221 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35873652	Derived	Gunnlaugsson A, Johannesson V, Wieslander E, Brun E, Bitzen U, Stahl O, Bratt O, Ahlgren G, Ohlsson T, Kjellen E, Nilsson P. A prospective phase II study of prostate-specific antigen-guided salvage radiotherapy and 68Ga-PSMA-PET for biochemical relapse after radical prostatectomy - The PROPER 1 trial. Clin Transl Radiat Oncol. 2022 Jul 5;36:77-82. doi: 10.1016/j.ctro.2022.07.001. eCollection 2022 Sep.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011469	Prostatic Diseases
D052801	Male Urogenital Diseases