Prostate CancerPhase 2PLATINNCT01903408
Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
A Phase 2 study testing Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB in people with Prostate Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to May 2020
- Phase
- Phase 2
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed prostate cancer with Gleason Score
- risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement
- Karnofsky Index >/= 70%
- age 18-75 years
- neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy
- written informed consent
Who cannot join
- stage IV (distant metastases)
- lymph node metastases outside the pelvis
- rising prostate-specific antigen (PSA) under antihormonal treatment
- severe wound complications after laparatomy
- severe lymph edema of the legs, elephantiasis, postthrombotic syndrome
- decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy
Show all 9Show fewer
- history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin)
- previous irradiation of the pelvic lymph nodes
- concurrent participation in a clinical trial that might influence the results of either trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Radiation Oncology, University Hospital Heidelberg
Heidelberg, 69120
About this study
Official title: Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.
Read the detailed description
The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate.
Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed.
Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.
- Conditions
- Prostate Cancer
- Being tested
- Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBRadiation
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Boost to prostate | Other | IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate (76.5 Gy) in 34 fractions Arm finished recruitment and follow-up Receives: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB |
| Arm 2: Boost to prostate and lymph node metastases | Other | IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate (76.5 Gy) \& pelvic lymph node mets (61.2 Gy) in 34 Fx Receives: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB |
| Arm 3: Boost to prostate bed | Other | IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate bed (68 Gy) in 34 fractions Arm finished recruitment and follow-up and is published Receives: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB |
| Arm 4: Boost to prostate bed and lymph node metastases | Other | IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) \& lymph node metastases (61.2 Gy) in 34 Fx Receives: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB |
| Arm 5: Boost to lymph node metastases | Other | Patients with previous irradiation of the prostate bed: IMRT of the pelvic lymphatic drainage (46.8 Gy) above the previous treatment fields, SIB to lymph node metastases (63.2 Gy) in 26 Fx Receives: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of safe feasibility (SDR)
Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.
Measured: 2 years
Secondary outcomes (2)
Biochemical recurrence free survival
Measured: 2 years
Quality of Life
Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMay 2009
- Primary completionMay 2018
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Klaus Tschira Stiftung gGmbH
- Responsible party
- Principal investigator, Klaus Herfarth, MD, Heidelberg University
- Investigators
- Klaus Herfarth, Prof. Dr., Principal investigator, University Hospital Heidelberg, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903408
- Sponsor's protocol ID
- Klaus Tschira 00.153.2009
- Other IDs
- ARO 2009-05
- Acronym
- PLATIN
- Status last verified
- Jan 2023
- First submitted
- 16 Jul 2013
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Habl G, Katayama S, Uhl M, Kessel KA, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial. BMC Cancer. 2015 Nov 7;15:868. doi: 10.1186/s12885-015-1886-5.
PubMed 26547188Katayama S, Habl G, Kessel K, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with integrated boost to the prostate bed - initial results of the PLATIN 3 Trial. BMC Cancer. 2014 Jan 14;14:20. doi: 10.1186/1471-2407-14-20.
PubMed 24422782Koerber SA, Winter E, Katayama S, Slynko A, Haefner MF, Uhl M, Sterzing F, Habl G, Schubert K, Debus J, Herfarth K. Elective Node Irradiation With Integrated Boost to the Prostate Using Helical IMRT-Clinical Outcome of the Prospective PLATIN-1 Trial. Front Oncol. 2019 Aug 13;9:751. doi: 10.3389/fonc.2019.00751. eCollection 2019.
PubMed 31456941
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
- ClinicalTrials.gov ID
- NCT01903408
- Acronym / sponsor ID
- PLATIN / Klaus Tschira 00.153.2009
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Klaus Tschira Stiftung gGmbH
- Study start
- May 2009 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 19 Jul 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.
For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.
Detailed description
The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate.
Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed.
Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Boost to prostate | Other | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBIMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate (76.5 Gy) in 34 fractions Arm finished recruitment and follow-up |
| Arm 2: Boost to prostate and lymph node metastases | Other | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBIMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate (76.5 Gy) \& pelvic lymph node mets (61.2 Gy) in 34 Fx |
| Arm 3: Boost to prostate bed | Other | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBIMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate bed (68 Gy) in 34 fractions Arm finished recruitment and follow-up and is published |
| Arm 4: Boost to prostate bed and lymph node metastases | Other | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBIMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) \& lymph node metastases (61.2 Gy) in 34 Fx |
| Arm 5: Boost to lymph node metastases | Other | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBPatients with previous irradiation of the prostate bed: IMRT of the pelvic lymphatic drainage (46.8 Gy) above the previous treatment fields, SIB to lymph node metastases (63.2 Gy) in 26 Fx |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically confirmed prostate cancer with Gleason Score
- risk of lymph node involvement >20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement
- Karnofsky Index >/= 70%
- age 18-75 years
- neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy
Key exclusion criteria (9 listed)
- stage IV (distant metastases)
- lymph node metastases outside the pelvis
- rising prostate-specific antigen (PSA) under antihormonal treatment
- severe wound complications after laparatomy
- severe lymph edema of the legs, elephantiasis, postthrombotic syndrome
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 |
|---|---|---|
| Intensity-modulated radiotherapy of the pelvic lymph nodes using SIBThe intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB) | Radiation | Arm 1: Boost to prostate, Arm 2: Boost to prostate and lymph node metastases, Arm 3: Boost to prostate bed, Arm 4: Boost to prostate bed and lymph node metastases, Arm 5: Boost to lymph node metastases |
Primary outcome
Rate of safe feasibility (SDR)
Time frame: 2 years
Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.
2 secondary outcomes
Biochemical recurrence free survival
Time frame: 2 years
Quality of Life
Time frame: 2 years
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 Feb 2023.
- Results publication: PubMed 26547188Habl G, Katayama S, Uhl M, Kessel KA, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial. BMC Cancer. 2015 Nov 7;15:868. doi: 10.1186/s12885-015-1886-5.
- Results publication: PubMed 24422782Katayama S, Habl G, Kessel K, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with integrated boost to the prostate bed - initial results of the PLATIN 3 Trial. BMC Cancer. 2014 Jan 14;14:20. doi: 10.1186/1471-2407-14-20.
- Results publication: PubMed 31456941Koerber SA, Winter E, Katayama S, Slynko A, Haefner MF, Uhl M, Sterzing F, Habl G, Schubert K, Debus J, Herfarth K. Elective Node Irradiation With Integrated Boost to the Prostate Using Helical IMRT-Clinical Outcome of the Prospective PLATIN-1 Trial. Front Oncol. 2019 Aug 13;9:751. doi: 10.3389/fonc.2019.00751. eCollection 2019.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Klaus Herfarth, Prof. Dr. principal investigator
University Hospital Heidelberg, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB in people with Prostate Cancer, run by Heidelberg University at 1 site in Germany.
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 6 inclusion and 9 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 Feb 2023. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of safe feasibility (SDR) (time frame: 2 years). 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 NCT01903408, which also lists 3 linked publications.
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 Feb 2023.