Relapsed Prostate Cancer Clinical Trial
— PROPEROfficial 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
| NCT number | NCT02699424 |
| Other study ID # | PP01 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | December 2019 |
| Verified date | May 2020 |
| Source | Lund University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Lund University Hospital | Lund |
| Lead Sponsor | Collaborator |
|---|---|
| Lund University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Assessment of PSA response post treatment. | Is evaluated at 6, 12, 24, and 60 months post-treatment. | ||
| Primary | 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 | ||
| Primary | Assessment of PSA response during radiotherapy. | Is evaluated once weekly during radiotherapy, duration of radiotherapy is 35 days; 70 Gy in 2 Gy fractions. |