Prostatic NeoplasmsPARAPLY-1NCT01962324
Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer
A study testing SIB Dose-Escalation Radiotherapy in people with Prostatic Neoplasms and Lymphatic Metastasis, run by Umeå University at 1 site in Sweden.
Trial summary
A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Lymphatic Metastasis
- What is being tested?
- SIB Dose-Escalation Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to 9 May 2023
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed high risk prostate cancer with a risk of lymphatic spread >15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
- Written informed consent
- > 18 years
- Fiducial gold markers implanted in the prostate (min 3)
Who cannot join
- • Non MR-safe implants or other contraindication to MRI
- WHO PS>1
- Previous pelvic irradiation
- TURP within 6 months
- IPSS >19
- Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
- Creatinin clearance < 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.
- Conditions
- Prostatic Neoplasms, Lymphatic Metastasis
- Being tested
- SIB Dose-Escalation Radiotherapy
- Keywords
- Quality of Life, Radiotherapy, Radiotherapy, dose-escalation
- Medical subject headings
- Prostatic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB Dose-Escalation RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| SIB Dose-Escalation radiotherapy | Experimental | Simultaneous integrated boost to intraprostatatic tumor and lymph nodes Receives: Radiation: SIB Dose-Escalation Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA progression free survival
PSA progression defined according to American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix definition: nadir PSA + 2 ng/mL (on three consecutive measurements with at least one month between each)
Measured: 36 months
Secondary outcomes (4)
Genitourinary Quality of Life
Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Measured: 0 6 12 36 60 months
Gastrointestinal Quality of Life
Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Measured: 0 6 12 36 60 months
Overall Quality of Life
Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Measured: 0 6 12 36 60 months
Sexual Quality of Life
Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Measured: 0 6 12 36 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startMar 2015
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Thellenberg Karlsson, Umeå University
- Investigators
- Camilla Thellenberg Karlsson, MD, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962324
- Sponsor's protocol ID
- PARAPLY-1
- Acronym
- PARAPLY-1
- Status last verified
- Feb 2024
- First submitted
- 9 Oct 2013
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
- ClinicalTrials.gov ID
- NCT01962324
- Acronym / sponsor ID
- PARAPLY-1 / PARAPLY-1
- Conditions
- Prostatic Neoplasms, Lymphatic Metastasis
- Keywords
- Quality of Life, Radiotherapy, Radiotherapy, dose-escalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 14 Oct 2013 (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.
A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIB Dose-Escalation radiotherapy | Experimental | Radiation: SIB Dose-Escalation RadiotherapySimultaneous integrated boost to intraprostatatic tumor and lymph nodes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed high risk prostate cancer with a risk of lymphatic spread >15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
- Written informed consent
- > 18 years
- Fiducial gold markers implanted in the prostate (min 3)
Key exclusion criteria (7 listed)
- • Non MR-safe implants or other contraindication to MRI
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 |
|---|---|---|
| SIB Dose-Escalation Radiotherapy | Radiation | SIB Dose-Escalation radiotherapy |
Primary outcome
PSA progression free survival
Time frame: 36 months
PSA progression defined according to American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix definition: nadir PSA + 2 ng/mL (on three consecutive measurements with at least one month between each)
4 secondary outcomes
Genitourinary Quality of Life
Time frame: 0 6 12 36 60 months
Gastrointestinal Quality of Life
Time frame: 0 6 12 36 60 months
Overall Quality of Life
Time frame: 0 6 12 36 60 months
Sexual Quality of Life
Time frame: 0 6 12 36 60 months
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 1 Mar 2024.
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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.
Camilla Thellenberg Karlsson, MD principal investigator
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIB Dose-Escalation Radiotherapy in people with Prostatic Neoplasms and Lymphatic Metastasis, run by Umeå University 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 4 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 1 Mar 2024. 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?
PSA progression free survival (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.