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NCT Number: NCT02699424

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

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.

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Key information

Conditions

Relapsed Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lund University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External radiation therapy

Radiation

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Assessment of PSA response post treatment.

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

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study 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

Acronym: PROPER

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2016
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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