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Charité HT-Prostate

Primary Purpose

Prostate Cancer, Recurrence

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Regional Hyperthermia

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Universitätsklinikum TübingenRecruiting
Universitätsklinikum ErlangenRecruiting
Charité Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined regional hyperthermia and salvage radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

Acute grade 3+ adverse events

Measured according to CTCAE version 4.

Secondary Outcome Measures

Late adverse events

According to CTCAE version 4.

Quality of life (QoL) assessment

Using EORTC questionnaires

Biochemical progression-free survival

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

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

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.

Full Information

NCT ID

NCT04159051

First Posted

November 6, 2019

Last Updated

November 7, 2019

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04159051

Brief Title

Charité HT-Prostate

Official Title

Phase II Studie Zur Hyperthermen Salvage-Radiotherapie Bei Prostatakarzinompatienten Mit Biochemischem Rezidiv Nach Prostatektomie

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Recruiting

Study Start Date

October 2016 (Actual)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The combination of regional hyperthermia and salvage radiotherapy is being tested in patients with biochemically recurrent prostate cancer after radical prostatectomy.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined regional hyperthermia and salvage radiotherapy

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Regional Hyperthermia

Intervention Description

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

Primary Outcome Measure Information:

Title

Acute grade 3+ adverse events

Description

Measured according to CTCAE version 4.

Time Frame

up to three months after end of treatment

Secondary Outcome Measure Information:

Title

Late adverse events

Description

According to CTCAE version 4.

Time Frame

up to 36 months after end of treatment

Title

Quality of life (QoL) assessment

Description

Using EORTC questionnaires

Time Frame

up to 36 months after end of treatment

Title

Biochemical progression-free survival

Description

PSA-rise > 0.4 ng/ml or increasing PSA-level where the initial PSA-level is above 0.4 ng/ml.

Time Frame

up to 36 months after end of treatment

Title

Clinical progression-free survival

Description

Time Frame

up to 36 months after end of treatment

Title

Time without androgen deprivation therapy (ADT), i.e., time until initiation of ADT

Description

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.

Time Frame

up to 36 months after end of treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pirus Ghadjar, Prof. Dr.

pirus.ghadjar@charite.de

Facility Information:

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

State/Province

Baden Württemberg

ZIP/Postal Code

72016

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arndt-Christian Müller, MD

Arndt-Christian.Mueller@med.uni-tuebingen.de

First Name & Middle Initial & Last Name & Degree

Arndt-Christian Müller, MD

Facility Name

Universitätsklinikum Erlangen

City

Erlangen

State/Province

Bayern

ZIP/Postal Code

91012

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Oliver Ott, Prof. Dr.

oliver.ott@uk-erlangen.de

First Name & Middle Initial & Last Name & Degree

Oliver Ott, Prof. Dr.

Facility Name

Charité Universitätsmedizin Berlin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pirus Ghadjar, Prof. Dr.

pirus.ghadjar@charite.de

First Name & Middle Initial & Last Name & Degree

Marcus Beck, MD

marcus.beck@charite.de

First Name & Middle Initial & Last Name & Degree

Marcus Beck, MD

First Name & Middle Initial & Last Name & Degree

Sebastian Zschaeck, MD

First Name & Middle Initial & Last Name & Degree

Peter Wust, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26152590

Citation

Muller AC, Zips D, Heinrich V, Lamprecht U, Voigt O, Burock S, Budach V, Wust P, Ghadjar P. Regional hyperthermia and moderately dose-escalated salvage radiotherapy for recurrent prostate cancer. Protocol of a phase II trial. Radiat Oncol. 2015 Jul 8;10:138. doi: 10.1186/s13014-015-0442-4.

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Charité HT-Prostate

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