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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 (PROPER)

Primary Purpose

Relapsed Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

External radiation therapy

About this trial

This is an interventional treatment trial for Relapsed Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Lund University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Tumor detection rate measured with Ga-PSMA-PET in non-responders versus responders.

Assessment of PSA response during radiotherapy.

Secondary Outcome Measures

Full Information

NCT ID

NCT02699424

First Posted

February 11, 2016

Last Updated

May 25, 2020

Sponsor

Lund University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02699424

Brief Title

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

Acronym

PROPER

Official Title

Prospective Evaluation of 68-Ga-PSMA -PET and Early PSA Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

March 2016 (Actual)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lund University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Relapsed Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy

Arm Type

Other

Intervention Type

Radiation

Intervention Name(s)

External radiation therapy

Primary Outcome Measure Information:

Title

Tumor detection rate measured with Ga-PSMA-PET in non-responders versus responders.

Time Frame

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

Title

Assessment of PSA response during radiotherapy.

Time Frame

Is evaluated once weekly during radiotherapy, duration of radiotherapy is 35 days; 70 Gy in 2 Gy fractions.

Other Pre-specified Outcome Measures:

Title

Assessment of PSA response post treatment.

Time Frame

Is evaluated at 6, 12, 24, and 60 months post-treatment.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adalsteinn Gunnlaugsson, MD, PhD

Organizational Affiliation

Lund University Hospital, Department of Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lund University Hospital

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35873652

Citation

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.

Results Reference

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