Preference-based Comparative Study on Definitive Radiotherapy of Prostate Cancer With Protons (ProtoChoice-P)

Technische Universität Dresden

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy with protons; Radiation: Radiotherapy with photons

Study type: Interventional

Funder types: Other

Identifiers

NCT02766686

STR - ProtoChoice-P - 2015

Details and patient eligibility

About

ProtoChoice-P is a prospective multicenter trial to evaluate proton therapy in patients suffering from prostate cancer. Primary aim of the study is a decrease of moderate or severe genito-urinary or intestinal side effects (Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 2 or higher) by the use of proton therapy. Secondary endpoints contain assessment of quality of life, biochemical recurrence and recurrence free survival as well as overall survival and economic comparison between photon and proton therapy.

Full description

The hypothesis of the study is a 7.5% decrease of combined genito-urinary and intestinal side effects from 15% with photon therapy to 7.5% by the use of protons. With an alpha of 0.05 and 80% power it is therefore necessary to treat 131 patients with protons to detect such difference. With an estimated drop-out rate of 10% 146 patients have to be recruited to the proton arm. As randomization to photon or proton therapy is not possible in a multicenter setting with only few proton facilities available patients treated with photons will be prospectively matched to their proton counterparts. Stratification criteria will include: Age, high dose volume, androgen deprivation, history of surgery, obstructive disease, increased risk for rectal bleeding, socio-economic criteria and use of rectal balloon during radiotherapy. Comparison of the primary endpoint will be restricted to patients without irradiation of lymphatic drainage.

Enrollment: 146 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• life expectancy ≥ 10 years
• adenocarcinoma of the prostate confirmed by punch biopsy
• locally limited to locally advanced adenocarcinomas without evidence of distant metastases i.e. T1-3b N0-1 M0
• stage-related indicated neoadjuvant / adjuvant androgen deprivation possible (neoadjuvant ≤ 6 months)
• good general condition (ECOG performance status 0 - 1)
• marker seed implantation before irradiation (optional) or possibility of Image-guided Radiation Therapy (IGRT) by CT
• adequate compliance for follow-up
• written informed consent

Exclusion criteria

• distant metastases
• previous radiotherapy of the lesser pelvis
• previous or concomitant other malignant disease except when there is no impact on treatment or follow-up of the prostate cancer
• participation in another clinical study, if it's excluded by the study protocols

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 3 patient groups

Radiotherapy with protons

Experimental group

Description:

Proton radiotherapy 74-80 Gray equivalent (GyE), 2Gy per fraction, 5 fractions peer week

Treatment:

Radiation: Radiotherapy with protons

Radiotherapy with photons

Active Comparator group

Description:

Photon-Intensity-Modulated Radiation Therapy (IMRT) without lymph drainage vessels, 74-80 Gy, 2Gray (Gy) per fraction, 5 fractions peer week

Treatment:

Radiation: Radiotherapy with photons

Radiotherapy with photons with lymph drainage vessels

Other group

Description:

Photon-IMRT with lymph drainage vessels, 74-80 Gy, 2Gy per fraction, 5 fractions peer week

Treatment:

Radiation: Radiotherapy with photons