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|ClinicalTrials.gov Identifier: NCT04159051|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
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|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy at least 12 weeks before randomization. Tumour stage pT2a-3b, R0-1, pN0 or cN0 according to the UICC TNM 2009; Gleason score available.
- PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/ml or three consecutive rises. The first value must be measured at least 4 weeks after radical prostatectomy.
- PSA at randomization ≤ 2 ng/ml.
- No evidence of macroscopic local recurrence or metastatic disease on pre-sRT-MRI (magnetic resonance imaging; with i.v. contrast) or pre-sRT-CT (multislice computed tomography with i.v. and oral contrast) of the abdomen and pelvis assessed within 16 weeks prior to randomization.
- WHO performance status 0-1 at randomization.
- Age at randomization between 18 and 80 years.
- Informed consent.
- Persistent PSA value 4-20 weeks after radical prostatectomy > 0.4 ng/ml.
- Palpable mass in the prostatic fossa, unless histology proves no evidence of recurrence.
- Pelvic lymph node enlargement >1 cm in short axis diameter of the abdomen and pelvis (cN1), unless the enlarged lymph node is sampled and negative.
- Presence or history of bone metastases. Bone scan is mandatory in cases of clinical suspicion (e.g., bone pain).
- Other malignancies within five years before planned sRT; non-melanoma skin cancers are allowed.
- ADT or bilateral orchiectomy.
- Previous pelvic radiotherapy.
- Hip prosthesis.
- Metal clusters/markers and patients with a pacemaker.
Severe or active co-morbidities impairing the feasibility of hyperthermia or dose intensified sRT including (but not exclusively limited to):
- chronic inflammatory bowel disease
- acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
- unstable angina pectoris and/or congestive heart failure requiring hospitalization within the last 6 months
- transmural myocardial infarction within the last 6 months
- chronic obstructive pulmonary disease exacerbation or other respiratory disorders requiring hospitalization or precluding planned treatment within the study at the time of randomization
- psychiatric disorder precluding understanding of information on trial-related topics, giving informed consent or filling out QoL questionnaires
- Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment in a clinical trial within 30 days prior to trial entry.
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.|
|Responsible Party:||Pirus Ghadjar, Head of Hyperthermia Unit, Charite University, Berlin, Germany|
|Other Study ID Numbers:||
|First Posted:||November 12, 2019 Key Record Dates|
|Last Update Posted:||November 12, 2019|
|Last Verified:||November 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|