Charité HT-Prostate

NCT04159051 | Unknown DMC

• 1 other identifier: EA2/110/15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer; Recurrence

Outcome Measures

Primary Outcomes (1)

• Acute grade 3+ adverse events

  Measured according to CTCAE version 4.

  up to three months after end of treatment

Secondary Outcomes (5)

• Late adverse events

  up to 36 months after end of treatment

• Quality of life (QoL) assessment

  up to 36 months after end of treatment

• Biochemical progression-free survival

  up to 36 months after end of treatment

• Clinical progression-free survival

  up to 36 months after end of treatment

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

  up to 36 months after end of treatment

Study Arms (1)

Combined regional hyperthermia and salvage radiotherapy

EXPERIMENTAL

Device: Regional Hyperthermia

Interventions

Regional Hyperthermia DEVICE

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

Combined regional hyperthermia and salvage radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (3)

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72016, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91012, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 26152590 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pirus Ghadjar, Prof. Dr.

CONTACT

pirus.ghadjar@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Hyperthermia Unit

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: October 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2024
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)