Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation.

The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histology-proven prostate cancer with Gleason Score and PSA-value;

indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;

Karnofsky-Index ≥ 70%

age ≥ 18 years

Disqualifiers

androgen deprivation therapy

lymphatic spread

macroscopic tumor/ R2

stage IV (M1)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypofractionated radiotherapy with photons

    Radiation

    hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)

  • Hypofractionated radiotherapy with protons

    Radiation

    hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)

  • Normofractionated radiotherapy with photons

    Radiation

    normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)

Treatment groups

897 Participants
are divided into 3 treatment groups
Group A: 70.0/ 2.0 Gray (RBE)Active comparator 1 intervention
Group B: 57.0/ 3.0 Gray (RBE)Experimental treatment 1 intervention
Group C: 57.0/ 3.0 (RBE)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of life (prostate-associated, 12 weeks vs baseline)

The primary objective of the present trial is to show a Change in the bowel symptoms according to scores on the EORTC QLQ-PR25 questionaire after proton therapy compared to photon irradiation (week 12 vs. baseline).

Time frame
12 weeks

Secondary outcomes

1

biochemical progression-free survival (bPFS)

non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS)

Time frame
5 years after baseline
2

overall survival (OS)

non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS)

Time frame
5 years after baseline
3

Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years

non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to toxicity

Time frame
2 and 5 years after baseline
4

Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)

non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to changes in the scores of quality of life based on the EORTC QLQ-C30 questionaire

Time frame
2 and 5 years after baseline

Other outcomes

Sponsors and contacts

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