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NCT Number: NCT04083937

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • androgen deprivation therapy
  • lymphatic spread
  • macroscopic tumor/ R2
  • stage IV (M1)
  • previous irradiation

Treatment and study plan

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)

Primary outcomes

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

    Time frame: 12 weeks

    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).

Secondary outcomes

  1. biochemical progression-free survival (bPFS)

    Time frame: 5 years after baseline

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

  2. overall survival (OS)

    Time frame: 5 years after baseline

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

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

    Time frame: 2 and 5 years after baseline

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

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

    Time frame: 2 and 5 years after 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

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

    Time frame: 2 and 5 years after 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-PR25 questionaire

Study contacts

Contact information is provided by the study sponsor or research team.

Juergen Debus

CONTACT

[email protected]

06221 56 8201

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: PAROS

Important dates

Study start
2018
Primary completion
2028
Study completion
2029
First posted
Sep 10, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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