NCT02699424

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

3.8 years

First QC Date

February 11, 2016

Last Update Submit

May 25, 2020

Conditions

Relapsed Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

Other Outcomes (1)

  • Assessment of PSA response post treatment.

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

Study Arms (1)

Radiotherapy

OTHER
Radiation: External radiation therapy

Interventions

External radiation therapyRADIATION
Radiotherapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 35873652DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Adalsteinn Gunnlaugsson, MD, PhD

    Lund University Hospital, Department of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2016

First Posted

March 4, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)