Relapsed Prostate CancerPROPERNCT02699424
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
A study testing External radiation therapy in people with Relapsed Prostate Cancer, run by Lund University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Relapsed Prostate Cancer
- What is being tested?
- External radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Relapsed Prostate Cancer
- Being tested
- External radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Other | Not described Receives: Radiation: External radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor detection rate measured with Ga-PSMA-PET in non-responders versus responders.
Measured: 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.
Measured: Is evaluated once weekly during radiotherapy, duration of radiotherapy is 35 days; 70 Gy in 2 Gy fractions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adalsteinn Gunnlaugsson, MD, PhD, Principal investigator, Lund University Hospital, Department of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699424
- Sponsor's protocol ID
- PP01
- Acronym
- PROPER
- Status last verified
- May 2020
- First submitted
- 11 Feb 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35873652
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02699424
- Acronym / sponsor ID
- PROPER / PP01
- Conditions
- Relapsed Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Other | Radiation: External radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External radiation therapy | Radiation | Radiotherapy |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 35873652Gunnlaugsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adalsteinn Gunnlaugsson, MD, PhD principal investigator
Lund University Hospital, Department of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External radiation therapy in people with Relapsed Prostate Cancer, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02699424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.