|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04159051|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Recurrence||Device: Regional Hyperthermia||Not Applicable|
Current studies on salvage radiotherapy (sRT) for biochemically recurrent prostate cancer after radical prostatectomy investigate timing, dose-escalation and androgen deprivation therapy (ADT) for recurrent prostate cancer. These approaches could either be limited by radiation-related susceptibility of the anastomosis or by suspected side-effects of ADT. A phase II protocol was developed to investigate the benefit and tolerability of regional hyperthermia with moderately dose-escalated sRT. The study hypothesis is that hyperthermic sRT is a safe and feasible salvage treatment modality. The primary endpoint is safety measured by frequency of grade 3+ genitourinary (GU) and gastrointestinal (GI) adverse events (AE) according to Common Toxicity Criteria (CTC) version 4. Feasibility is defined by number of hyperthermia treatments (n ≥ 7) and feasibility of sRT according to protocol. Target volume delineation is performed according to the EORTC guidelines. sRT is administered with single doses of 2 Gy 5×/week to a total dose of 70 Gy to the prostate bed, or alternatively the total dose only to the area of highest risk and a lower dose to the remaining prostate bed using a simultaneous boost (SIB) technique. Regional hyperthermia is given 2×/week to a total of 10 treatments. German centres participate in the phase II trial using intensity modulated RT (IMRT), volumetric modulated arc technique (VMAT) or tomotherapy. The initiating centres were participants of the SAKK 09/10 study, where the same patient criteria and target volume definition (mandatory successful performed dummy run) were applied insuring a high standardisation of the study procedures.
The introduced phase II study implements modern sRT and regional hyperthermia. If the phase II study is found to be safe and feasible, a multicenter phase III study might be performed to test whether the addition of regional hyperthermia to dose-intensified sRT improves biochemical control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Studie Zur Hyperthermen Salvage-Radiotherapie Bei Prostatakarzinompatienten Mit Biochemischem Rezidiv Nach Prostatektomie|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2024|
|Experimental: Combined regional hyperthermia and salvage radiotherapy||
Device: Regional Hyperthermia
Regional hyperthermia 1-2×/week to a total number of 7-10 treatments combined with salvage radiotherapy to a total dose of 70 Gy over 7 weeks
- Acute grade 3+ adverse events [ Time Frame: up to three months after end of treatment ]Measured according to CTCAE version 4.
- Late adverse events [ Time Frame: up to 36 months after end of treatment ]According to CTCAE version 4.
- Quality of life (QoL) assessment [ Time Frame: up to 36 months after end of treatment ]Using EORTC questionnaires
- Biochemical progression-free survival [ Time Frame: up to 36 months after end of treatment ]PSA-rise > 0.4 ng/ml or increasing PSA-level where the initial PSA-level is above 0.4 ng/ml.
- Clinical progression-free survival [ Time Frame: up to 36 months after end of treatment ]Occurrence of a local recurrence, regional recurrence or distant metastasis. Clinical progression-free survival is defined as the time between trial inclusion and occurrence of clinical progression, start of a new androgen deprivation therapy (see below) or death. Patients without event will be censored at the time of last follow-up.
- Time without androgen deprivation therapy (ADT), i.e., time until initiation of ADT [ Time Frame: up to 36 months after end of treatment ]The time from trial inclusion until start of a new androgen deprivation therapy. Patients without new ADT will be censored at the time of last follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159051
|Contact: Pirus Ghadjar, Prof. Dr.||email@example.com|
|Tübingen, Baden Württemberg, Germany, 72016|
|Contact: Arndt-Christian Müller, MD Arndt-Christian.Mueller@med.uni-tuebingen.de|
|Principal Investigator: Arndt-Christian Müller, MD|
|Erlangen, Bayern, Germany, 91012|
|Contact: Oliver Ott, Prof. Dr. firstname.lastname@example.org|
|Principal Investigator: Oliver Ott, Prof. Dr.|
|Charité Universitätsmedizin Berlin||Recruiting|
|Berlin, Germany, 13353|
|Contact: Pirus Ghadjar, Prof. Dr. email@example.com|
|Contact: Marcus Beck, MD firstname.lastname@example.org|
|Principal Investigator: Marcus Beck, MD|
|Sub-Investigator: Sebastian Zschaeck, MD|
|Sub-Investigator: Peter Wust, Prof. Dr.|